Recommendations

IAP Guidelines 2006 on Management of young infant and severely malnourished subjects.
Acute Diarrhea Several important developments had been made in
the field of management of diarrhea in children as a
result of research done in India and globally. The
Writing Committee objective of this meeting was to take follow-up
Shinjini Bhatnagar* steps to ensure that the benefits of new knowledge
Rakesh Lodha* reach affected children in India and at the
Panna Choudhury** same time ensure that new products are not
H.P.S. Sachdev*** inappropriately used.
Nitin Shah† The meeting was convened to achieve a
Sushma Narayan†† consensus on these issues based on careful review
Nitya Wadhwa* of the literature and keeping in mind the
Preeti Makhija* requirements of treatment of individual children as
Keya Kunnekel* well as the needs of Diarrheal Diseases National
Deepak Ugra‡ Control Program. As individual studies are often
too small to yield precise estimation of effect size,
the recommendations were largely based on pooled
Background data or meta-analysis of randomized placebo
controlled trials. These recommendations were
IAP National Task Force for framing Guidelines
published in the official journal of the Academy,
on the Management of Diarrhea, August 2003.
Indian Pediatrics in April 2004(1). Based on these
The Indian Academy of Pediatrics National recommendations some policy changes took place
Task Force for framing Guidelines on the at the National level.
Management of Diarrhea in children convened a IAP National Task Force for Framing
meeting at the All India Institute of Medical Guidelines on the Management of Diarrhea,
Sciences under the chairmanship of Professor MK May 2006 held under IAP Action Plan 2006
Bhan in August 2003, to revise the guidelines for
management of diarrhea in children. The focus of The Indian Academy of Pediatrics decided
this review was oral rehydration solutions, zinc and under IAP Action Plan 2006 in 2006 that it would
probiotics in acute diarrhea, drug treatment of further consolidate the above recommendations and
dysentery, and management of diarrhea in the take steps to increase awareness amongst
pediatricians and other physicians for the revised
* All India Institute of Medical Sciences, New Delhi. guidelines for management of diarrhea. A core
** Maulana Azad Medical College and LNJP Hospital, committee was formulated to review all the
New Delhi. relevant literature based on pooled data or meta-
*** Sitaram Bhartia Institute of Science and Research,
analysis of randomized placebo controlled trials for
New Delhi.
† National President IAP 2006
oral rehydration solutions, zinc, probiotics and
†† Kasturba Hospital, New Delhi. antisecretory drugs in acute diarrhea, drug
‡ Secretary General IAP 2006. treatment of dysentery, and management of
Correspondence to: Dr. Shinjini Bhatnagar, Center for severely malnourished subjects. New data, if any,
Diarrheal Disease and Nutrition Research, Depart- published after the last consensus meeting was
ment of Pediatrics, All India Institute of Medical Sci- reviewed. The data was presented at a workshop to
ences, New Delhi 110 029, the members of the Task Force (Members are listed
E-mail: shinjini_bhatnagar@[Link]. in annexure) at the IAP National Consensus

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Meeting on Acute Diarrhea held on 6th May 2006. Review of clinical trials of reduced osmolarity
We summarize below the revised consensus oral rehydration salts solutions
recommendations (and wherever relevant the
rationale) of the group. For sections on reduced (a) Children with acute non-cholera diarrhea
osmolarity ORS and zinc the literature presented is The published meta-analysis of trials of reduced
similar to the earlier report with some minor osmolarity ORS was reviewed(3). It included all
modifications. randomized trials in which a reduced osmolarity
A. Reduced Osmolarity ORS in Acute Diarrhea ORS containing glucose, maltodextrin or sucrose
(total osmolarity 210-268 mosmol/L) and a sodium
The current standard WHO ORS has a sodium concentration ranging from 50 to 75 mEq/L
concentration of 90 mEq/L (glucose 110 mmol/L, was used. These studies were conducted mainly
osmolarity 311 mOsm/L), which corresponds to the in developing countries and included well-
stool electrolyte composition in toxin-mediated nourished and malnourished children aged 1 month
diarrhea. However it has worked well even in to 5 years with acute diarrhea of duration <7
young children with non-cholera diarrhea when days with dehydration. Four of the studies were
used according to the recommended guidelines done in India, two as part of large multi-center
with ready access to plain water during oral trials.
rehydration.
Results of the meta-analysis were as follows:
Several considerations lead to the clinical (i) Use of reduced osmolarity ORS was associated
evaluation of reduced osmolarity oral rehydration with a significant 39% reduction in need for IVF;
salts solutions and they have been examined by need for IVF was considered an important outcome
WHO(2). Initially, one main concern was the measure as in many peripheral health facilities,
potential risk of hypernatremia with standard where IV therapy is often unavailable, reducing the
WHO-ORS in children with non-cholera diarrhea. need for unscheduled IV therapy would reduce the
There was also the recognition that the standard risk of death from dehydration, (ii) 19% reduction
WHO-ORS may provide too much sodium to in stool output and (iii) 29% lower incidence of
edematous children. In later years, there were vomiting (Table I). The incidence of hyponatremia
reports of recurrent dehydration in young infants L(serum sodium <130 mEq/L) at 24 hours
treated with standard WHO-ORS on a weight to evaluated in 3 clinical trials was greater among
volume basis as replacement of ongoing stool children given reduced osmolarity ORS. 51
losses, that was promptly reversed when patients children treated with reduced osmolarity ORS and
were kept nil orally and on intravenous fluid 36 children treated with standard WHO ORS
regimens. Finally, laboratory experiments showed developed hyponatremia (OR = 1.45. 95% CI: 0.93
that reduced osmolarity solutions (sodium 60 to 2.26). None of these children were symptomatic.
mmol/L, glucose 80-120 mmol/L, osmolarity 240 This difference was not statistically significant but
mosmol/L) promote water and sodium absorption could be as much as twice that associated with
more efficiently than the WHO-ORS. standard WHO ORS.

TABLE I– Summary of the Results of the Published Meta-analysis of all Randomized Clinical Trials Comparing Reduced
Osmolarity ORS with Standard WHO ORS in Children with Acute Non-cholera Diarrhea

Outcome Number of studies Reduction in odds (95%CI) for childrenreceiving reduced osmolarity ORS when
reporting compared to those receiving standard WHO ORS (311 mosmol/l)
Unscheduled IV 9 39% (19%, 53%)
Stool output 12 19% (12%, 26%)
Vomiting 6 29% ( 8%, 45%)
Adapted from reference 2 and 3

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Analysis of ORS efficacy stratified for sodium study (sodium 75 mEq/L, glucose 75 mmol/L,
content osmolarity 245mosm/L). In the other two studies,
however, stool output was reduced by about 30% in
An analysis of all studies was conducted (2), children with cholera who were treated with
stratifying them according to the sodium content of reduced osmolarity ORS.
the reduced osmolarity ORS: (i) reduced
osmolarity ORS containing less than 75 mEq/L of (c) Reduced osmolarity ORS in adults with cholera
sodium (range 60 to 70 mEq/L), and (ii) reduced
osmolarity ORS containing exactly 75 mEq/L of The combined analysis of three studies(2) that
sodium. Table II shows the comparison of each of compared the efficacy and safety of reduced
the two types of reduced osmolarity ORS with osmolarity ORS (osmolarity 245-249 mosm/L) to
standard WHO ORS and not a direct comparison that of standard WHO ORS in adults with cholera
with each other. ORS solution with a sodium showed a minimal, and statistically insignificant,
concentration of 75 mEq/L and sodium con- mean reduction of 0.5 ml/kg (95% CI: –14.6 to
centration of less than 75 mEq/L are both more +15.6) in stool output during the first 24 hours
effective than standard WHO ORS with regard to among patients given reduced osmolarity ORS. A
need for unscheduled IV therapy and occurrence of small, but statistically significant reduction in mean
vomiting and that the incidence of hyponatremia, serum sodium of 1.3 mEq/L (95% CI: 0.3 to 2.3)
while not significantly higher than for standard was observed at 24-hours in patients treated with
WHO ORS, could be up to double its incidence. reduced osmolarity ORS when compared to those
Although the effect size suggests a trend that is given standard WHO ORS. None of these patients
consistent with greater reduction in stool output in who developed hyponatremia became sympto-
the ORS with sodium concentration of less than matic.
75 mEq/L, the test for interaction could not Recommendations by the WHO Task Force,
differentiate between the efficacy of ORS solution New York, July 2001
with a sodium concentration of 75 mEq/L and and
that of ORS solution containing sodium less The WHO Meeting of Experts(2) concluded
than 75 mEq/L, even on unidirectional tests of that there are programmatic and logistic advantages
significance. of using a single solution around the world for all
causes of diarrhea in all ages. After reviewing the
(b) Children with acute cholera diarrhea data the group of experts proposed that reduced
osmolarity ORS with 75 mEq/L of sodium and 75
In the pooled data(3) of all studies with cholera
mmol/L of glucose is effective in adults and
diarrhea in children there was a small, but
children with cholera and that reduced osmolarity
statistically significant reduction, in mean serum
ORS solution with 60 mEq/L of sodium does not
sodium at 24 hours in patients receiving reduced
seem to be significantly better than reduced
osmolarity ORS (sodium 70-75 mEq/L, glucose 75-
osmolarity ORS solution containing 75 mEq/L of
90 mmol/L, osmolarity 245-268 mOsm/L) when
sodium. They concluded that safety data in patients
compared with those given standard WHO ORS
with cholera, while limited, are reassuring.
[(mean difference 0.8 mEq/L, 95% CI: 0.6 to 1.0).
The children receiving reduced osmolarity ORS did The WHO Meeting of Experts(2) further
not have a higher risk, than those receiving recommended that this formulation falls within the
standard WHO ORS, of developing hyponatremia ranges defined by the WHO’s Program for the
(serum sodium <130 mEq/L) at 24 hours (RR = Control of Diarrheal Diseases (CDD) in March
1.8, 95% CI: 0.9 to 3.2), but a possible doubling of 1992 for a safe and efficacious oral rehydration
the incidence cannot be ruled out based on the solution, which, therefore, remain unchanged. The
confidence intervals. None of these children with recommended ranges were that the total substance
hyponatremia were symptomatic. Stool output at concentration (including that contributed by glu-
24-hours was not different between treatment cose) should be within the range 200-311 mmol/L.
groups in children with cholera in the multicenter The individual substance concentration of glucose

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TABLE II–Pooled Analysis Stratified According to the Sodium Content of the Reduced Osmolarity ORS

Reduced OSM ORS Reduced OSM ORS

with < 75 mEq/L with 75 mEq/L
of sodium in comparison of sodium in comparison
to standard WHO ORS to standard WHO ORS

Odds ratio (95%CI) for unscheduled IV N = 4 studies N = 4 studies

therapy for patients given RED OSM N = 678 children N = 1175 children
ORS when compared to those given 0.65 (0.41 to 1.00) 0.56 (0.39 to 0.80)
standard WHO ORS
Ratio of geometric means (95%CI) for N = 8 studies N = 4 studies
stool output in children given RED OSM N = 771 children N = 1049 children
ORS when compared to those given 0.69 (0.49 to 0.98) 0.88 (0.71 to 1.06)
standard WHO ORS
Odds ratio (95%CI) for vomiting for N = 3 studies N = 3 studies
patients given RED OSM ORS when N = 270 children N = 1031 children
compared to those given standard WHO ORS 0.49 (0.27 to 0.91) 0.74 (0.58 to 0.95)
Odds ratio (95%CI) for hyponatremia N = 3 studies N = 3 studies
(<130 mEq/L) for patients given RED OSM N = 139 children N = 1120 children
ORS when compared to those given standard Not analyzed 1.45 (0.93 to 2.26)
WHO ORS

Reproduced from reference 2.

should at least equal that of sodium, but should not all types of diarrhea. The group noted that the new
exceed 111 mmol/L and that of sodium should be improved universal ORS recommended by the
within the range of 60-90 mmol/L. The WHO containing sodium 75 mmol/L and glucose
concentrations of potassium, citrate and chloride 75 mmol/L, osmolarity 245 mosmol/L was
should be within the range of 15-25 mmol/L, 8-12 acceptable for all ages and measures should be
mmol/L and 50-80 mmol/l respectively as shown taken by the Government to improve its availability
in below(1). and reduce its cost. However it was proposed that
two formulations could be recommended so that
Recommendations of the IAP National Task the formulation containing sodium 60 mmol/L,
Force for use of ORS in diarrhea, August, 2003 glucose 84 mmol/L, osmolarity 224 mosmol/L is
The IAP National task Force(1) recommended identified as more suitable for children. The group
that all doctors should prescribe ORS for all ages in suggested that formulations ORS A and ORS
citrate allowed in the Indian Pharmacopia, 1996(2)
(2)
(1)
WHO recommended Range for Safe and Efficacious The two ORS formulations in the IP, 1996 are:
Oral Rehydration Solution ORS-A ORS-citrate
The total substance concentration should be within the (the current WHO
range 200-311 mmol/L (including that contributed by formulation)
glucose) Sodium chloride 3.5g 3.5g
The individual substance concentration of: Potassium chloride 1.5g 1.5g
Glucose should at least equal that of sodium,
Sodium citrate 2.9g 2.9g
but should not exceed 111 mmol/L
Anhydrous dextrose 27g 20g
Sodium should be within the range of 60-90 mmol/L
Potassium should be within the range of 15-25 mmol/L or
Citrate should be within the range 8-12 mmolL Dextrose monohydrate 29.7 20g
Chloride should be within the range 50-80 mmol/L ORS-A contains glucose in very high concentrations.

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should no longer be used and only the above 3. The powder packet to make 1 liter of solution
recommended formulations be in the market(3). The should be continued. Since mothers tend to use
powder packet to make 1 liter of solution should be ORS a glass at a time, a measuring device
continued. Since mothers tend to use ORS a glass at should be included inside to measure the
a time, a measuring device should be included required amount of powder accurately for 200
inside to measure the required amount of powder ml of fluid.
accurately for 200 mL of fluid. The group did not
recommend marketing of ORS with additives 5. The group was deeply concerned that ORS use
(probiotics, minerals). They should only be rates continued to be very low in several regions
permitted after demonstrating benefit in studies across the country. The group decided that
carried out in Indian patients as breast-feeding efforts will be made by the IAP to increase
rates, dietary patterns and etiology of diarrhea are awareness among pediatricians and other
different from the west. physicians for use of ORS by organizing
regional meetings and workshops. It
Recommendations by the Government of India, recommended that measures should be taken by
2004 the Government to improve ORS availability
and reduce its cost. There should be provision
Based on the WHO/UNICEF and the IAP for ORS to be available with the ASHA and the
recommendations a National Expert Group aanganwari workers.
formulated by the Ministry of Health, Government
of India recommended that a single universal ORS 6. The group did not currently recommend
solution containing sodium 75 mmol/L and glucose marketing of ORS with additives (probiotics,
75 mmol/L, osmolarity 245 mosmol/L was accept- minerals). They should only be permitted after
able for all ages and all types of diarrhea. The demonstrating benefit in studies carried out in
revised formulation was approved by the Drug Indian patients as they had different breast-
Controller of India and the Government formally feeding rates, dietary patterns and diarrhea
launched it in June 2004. etiology from the west.

Revised Recommendations of the IAP National B. Zinc in the Treatment of Acute Diarrhea
Task Force for Use of ORS in Diarrhea, May
2006 The rationale for use of specific nutrients as
1. ORS should be prescribed by all physicians for treatment of acute diarrhea is based on their effects
all ages in all types of diarrhea. on immune function or on intestinal structure or
function and on the epithelial recovery process
2. The group noted that the new improved ORS during diarrhea.
recommended by the WHO/UNICEF contain-
ing sodium 75 mmol/L and glucose 75 mmol/L, Zinc deficiency has been found to be
osmolarity 245 mosmol/L is the universal widespread among children in developing
solution for all ages and all types of diarrhea. countries, and occurs in most of Latin America,
Africa, the Middle East and South Asia. Zinc has
(3) Composition of Currently WHO/IAP/GOI been identified to play a critical role in metallo-
Recommended Reduced Osmolarity ORS enzymes, polyribosomes, the cell membrane, and
Component Concentration (mmol/L) cellular function, leading to the belief that it also
Sodium 75 plays a central role in cellular growth and in the
function of the immune system. Intestinal zinc
Chloride 65
losses during diarrhea aggravate pre existing
Potassium 20
zinc deficiency. Convincing evidence for its
Citrate 10 clinical importance has come from recent
Glucose 75 randomized controlled trials of zinc during acute
Osmolarity 245 diarrhea.

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Clinical efficacy of zinc as an adjunct to oral 22%) and resulted in a 34% reduction (95% CI
rehydration therapy in acute diarrhea 17% to 48%) in the odds of acute episodes lasting
>7 days (Bahl, Bhan and Bhatnagar, personal
The results of pooled analyses(4) of zinc communication). The study by Bhatnagar et al(5) is
treatment trials in children with acute diarrhea and of interest as it was hospital based, involved cases
the findings of subsequent studies are summarized of acute diarrhea with dehydration and measured
in Table III. The main features of these trials impact on stool output. In the zinc treated children,
include the randomized placebo controlled design, the total stool output was reduced by 31% (95% CI
subjects’ aged between 6 months and 3 years, and 1% to 52%) than in the placebo group.
daily elemental zinc dose ranging from 10 to 30 mg
per day. The effect of zinc did not vary significantly
with age, or nutritional status assessed by anthro-
In the trials subjected to pooled analysis, zinc pometry. The effects were not dependent upon the
supplemented children had 16% faster recovery type of zinc salts: zinc sulfate, zinc acetate or zinc
(95% CI 6% to 22%). Zinc treatment also resulted gluconate. Studies have shown that there seems to
in a 20% reduction (95% CI -2% to 38%) in the be little gain in efficacy when the commonly used
odds of acute episodes lasting >7 days. A combined 20mg daily dose of elemental zinc was increased to
meta-analysis of all the studies (all studies included 30-40mg daily. Majority of the studies so far were
in the pooled analysis and the subsequent trials) conducted in South East Asia, where zinc
done till now showed that zinc supplemented deficiency is common. Finally, there are relatively
children had 16% faster recovery (95% CI 11% to few data on children aged less than 6 months to

TABLE III– Results of Pooled-Analysis and Subsequent Randomized Controlled Trials in Children with Acute Diarrhea
Comparing Impact of Zinc with that of Placebo

Study No. of subjects Effect size (95% CI)

Risk of continuation of diarrhea Relative hazards
Pooled analysis (3) 1252/1194 0.85 (0.76 to 0.95)
Subsequent studies in South East Asia Strand et al(6) 442/449 0.79 (0.68 to 0.93)
Bahl et al (7) 404/401 0.89 (0.80 to 0.99)
Bhatnagar et al (5) 132/134 0.76 ( 0.59 to 0.97 )
Combined estimate (Meta-analysis) 5614 0.84 (0.78 to 0.89)*
Diarrhea lasting >7 days Odds Ratio
Pooled analysis 1252/1194 0.78 (0.56 to 1.09)
Subsequent studies in South East Asia
Strand et al 442/449 0.57 (0.38 to 0.86)
Bahl et al 404/401 0.61 (0.33 to 1.12)
Bhatnagar et al 132/134 0.09 (0.01 to 0.73)
Combined estimate (Meta-analysis) 4362 0.66 (0.52 to 0.83)*
Stool output Difference in means or Ratio of
Geometric Means
Roy et al (8) 57/54 –91g
Dutta et al (9) 44/36 –900g (-1200 to -590)
Bhatnagar et al 132/134 0.69 g/kg (0.48, 0.99)
Stool output per Ratio of GM (95% day of
diarrhoea CI) of geometricmeans
Bhatnagar et al 266 0.76 (0.59, 0.98)*

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allow any conclusions about efficacy in this age intestinal permeability, which is reversed by
group. supplementation.

Another study conducted in Bangladesh(10) WHO constituted a Task Force consisting of a

used a cluster randomized design to evaluate the group of experts, which met in New Delhi in May
effect on mortality and morbidity of providing 2001(11). They reviewed all the studies done till
daily zinc for 14 days to children with diarrhea as 2001 and concluded that:
part of the diarrhea treatment program in the
1. Zinc supplementation, given at a dose of about 2
community. The intervention and the comparison
RDA per day (20 mg per day for >6 months and
clusters were both given ORS and advice on
10 mg per day for younger than 6 months) for 14
feeding during diarrhea. The children in the zinc
days, is efficacious in significantly reducing
cluster had a shorter duration (hazard ratio 0.76,
severity of diarrhea as well as duration of the
95%CI 0.65 to 0.90) and lower incidence of
episode.
diarrhea (rate ratio 0.85, 95%CI 0.76 to 0.96) than
children in the comparison group. There was lesser 2. They recommended effectiveness studies to
admission to hospital of children with diarrhea (rate assess different strategies for delivering zinc
ratio 0.76; 95% CI 0.59 to 0.98), and lower supplementation to children with diarrhea.
mortality due to non injury deaths, notably diarrhea These studies should investigate the feasibility,
or pneumonia (rate ratio 0.49; 95% CI 0.25 to 0.94) sustainability and cost effectiveness of different
in the zinc treated cluster. The data are consistent in zinc delivery mechanisms, and monitor
showing a beneficial effect of zinc in acute variables such as ORS solution consumption,
diarrhea. antibiotic use rate, non diarrhea morbidity and
overall mortality. They recommended further
Zinc fortified ORS research to determine the effect of zinc
supplementation in young infants.
The efficacy of 40 mg elemental zinc mixed
with a liter of standard WHO ORS solution was Recommendations of the IAP National Task
compared with ORS without zinc and with zinc Force for use of zinc in diarrhea, August 18-19,
syrup administered separately from ORS(7). While 2003(1)
zinc-ORS was superior to ORS alone, it was less Based on studies in India and other developing
efficacious in reducing duration of the episode than countries there is sufficient evidence to recommend
zinc supplements given separately from the ORS zinc in the treatment of acute diarrhea as adjunct to
solution. The data are currently too limited. oral rehydration. However, ORS remains the
Results of a large randomized controlled trials are mainstay of therapy during acute diarrhea and zinc
awaited. has an additional modest benefit in the reduction of
stool volume and duration of diarrhea as an adjunct
The therapeutic benefits in acute diarrhea may
to ORS. Under all circumstances, oral rehydration
be attributed to effects of zinc on various
therapy must remain the main stay of treatment.
components of the immune system and its direct
Treatment of acute diarrhea with zinc may have
gastrointestinal effects. Zinc deficiency is
benefits on morbidity and mortality from other
associated with lymphoid atrophy, decreased
childhood infections and these should be further
cutaneous delayed hypersensitivity responses,
investigated. A uniform dose of 20 mg of elemental
lower thymic hormone activity, a decreased
zinc should be given during the period of diarrhea
number of antibody forming cells and impaired T
and for 7 days after cessatio diarrhea to children
killer cell activity. Zinc deficiency has also been
older than 3 months. Recommendations for below
recently shown to affect the differentiation of CD4
3 months must await further research.
response towards Th1 rather than Th2 pathway.
The direct intestinal effects of zinc deficiency Based on all the studies the group proposed that
include decreased brush border activity, enhanced zinc salts e.g., sulphate, gluconate or acetate may
secretory response to cholera toxin, and altered be recommended.

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The industry should be encouraged to prepare a 4. Iron containing formulations should not be used
zinc formulation, which contains only zinc. Iron with zinc as iron interferes with zinc absorption.
containing formulations should not be used with
5. The group recommended that both zinc and ORS
zinc as iron interferes with zinc absorption.
be made available at all parts of the country
Addition of zinc to current case management including remote areas. This will facilitate early
strategy in primary health setting in India initiation of treatment and also reduce the
family’s expenditure on irrational therapy
Since the earlier recommendations addition of during diarrhea.
zinc to current case management strategy in
6. IAP would organize workshops and seminars to
primary health setting has been evaluated in
increase the awareness for this intervention
developing country settings including in India.
amongst pediatricians, and other health care
Antibiotic use was less (70% (95% CI 65 to 75) in
providers.
areas where 20 mg zinc was introduced with ORS
and the ORS use rates increased by 50% (P <0.01) Recommendations by the Government of India,
in comparison with the group which did not receive 2007
zinc(12). Similar results were seen in a large
multicentre study done across India, Brazil, Based on the WHO/UNICEF and the IAP
Ethiopia, Egypt, and the Philippines(13). Bhandari recommendations and the data available on the
et al showed that ORS use rates increased and use evaluation of addition of zinc to current case
of injections and antimicrobials decreased signi- management strategy in primary health setting
ficantly from the baseline six months after zinc was [(14) and personal communication of a larger study
added to ORS in the management of diarrhea(14). by Bhandari, et al.] the Ministry of Health,
Government of India has recommended that 20 mg
Revised recommendations of the IAP National of elemental zinc should be given to all children
Task Force for use of zinc in diarrhea, May 2006 with diarrhea, older than 6 months, and should be
started as soon as diarrhea starts and continued for a
The group reviewed the literature again and
total period of 14 days. Children aged 2 months to 6
concluded that adequate evidence was available to
months should be advised 10 mg per day of
show that that zinc supplementation reduced the
elemental zinc for a total period of 14 days.
duration and severity of diarrhea. ORS remains an
essential component of the management of C. Probiotics and Antisecretory Agents in the
childhood diarrhea. The consensus recommen- Treatment of Diarrhea
dations of the group were:
Conclusions of the IAP National Task Force for
1. All cases of diarrhoea should receive zinc in use of probiotics in diarrhea, May 2006
addition to ORS. A uniform dose of 20 mg of
elemental zinc should be given to all children The group recommended that there is presently
older than 6 months and should be started as insufficient evidence(1) to recommend probiotics
soon as diarrhea starts and continued for a total in the treatment of acute diarrhea in our settings as:
period of 14 days. Children aged 2 months to 6
months should be advised 10 mg per day of 1. Almost all the studies till now were done in
elemental zinc for a total period of 14 days. developed countries. It may not be possible to
extrapolate the findings of these studies to our
2. Based on all the studies the group proposed that setting where the breast feeding rates are high
zinc salts e.g. sulphate, gluconate or acetate may and the microbial colonization of the gut is
be recommended. different.
3. The industry should be encouraged to prepare 2. The effect of probiotics is strain related and
dispersible tablets that are reasonably priced, there is paucity of data to establish the efficacy
can be stored and transported easily. They can be of the probiotic species (namely L. acidophilus,
dissolved in breast milk or water before use.

INDIAN PEDIATRICS 387 VOLUME 44__MAY 17, 2007

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Lactic Acid Bacteria) available in the Indian Consensus statement of IAP National Task Force:
market. To recommend a particular species it Status report on management of acute diarrhea. Indian
Pediatrics 2004;41: 335-348.
will have to be first evaluated in randomized
controlled trials in Indian children. 2. Reduced osmolarity oral rehydration salts (ORS)
formulation. A report from a meeting of experts jointly
3. The earlier studies have documented a beneficial organized by UNICEF and WHO. UNICEF HOUSE,
effect on rotavirus diarrhea which was present in New York, USA, 18 July, 2001. WHO/FCH/CAH/
>75% of cases in studies from the west. 0.1.22
Rotavirus constitutes about 25% of diarrhea in 3. Hahn SK, Kim YJ, Garner P. Reduced osmolarity oral
hospitalized children and 15% in outpatient rehydration solution for treating dehydration due to
practice in India. diarrhoea in children: systematic review. British
Medical Journal, 2001; 323: 81-85.
4. The primary outcome analyzed in all the studies
was the duration of diarrhea. The more objective 4. Zinc Investigators’ Collaborative Group. Bhutta ZA,
parameter of stool output was not evaluated. Bird SM, Black RE, Brown KH, Gardner JM, Hidayat
A et al. Therapeutic effects of oral zinc in acute and
5. There is an urgent need to study the following persistent diarrhea in children in developing countries:
issues before probiotics may be considered for pooled analysis of randomized controlled trials. Am
J Clin Nutr 2000; 72: 1516-1522.
treatment of diarrhea:
5. Bhatnagar S, Bahl R, Sharma PK, Kumar GK, Saxena
• Strain standardization SK, Bhan MK. Zinc treatment with oral rehydration
• Product regulation therapy reduces stool output and duration of diarrhea
in hospitalized children; a randomized controlled
• Evaluation of more than one strain for trial. J Pediatr Gastroenterol Nutr 2004; 38:
therapeutic effect 34-40.
• Evaluation of probiotics in subgroups 6. Strand TA, Chandyo RK, Bahl R, Sharma PR, Adhikari
• Dose and duration of therapy RK, Bhandari N, et al. Effectiveness and efficacy
of zinc for the treatment of acute diarrhea in
• Carrier substances young children. Pediatrics. 2002 May;109: 898-
• Interactions with other medication 903.

• Interactions with other enteropathogens 7. Bahl R, Bhandari N, Saksena M, Strand T, Kumar G.T,
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acute diarrhea. J Pediatr 2002;141:677-682.
There is presently not enough evidence on 8. Roy SK, Tomkins AM, Akramuzzaman SM, Behrens
either safety or efficacy of antisecretory drugs like RH, Haider R, Mahalanabis D et al. Randomized
racecadotril for its routine use in the treatment of controlled trial of zinc supplementation in
diarrhea. There is no data from our settings. malnourished Bangladeshi children with acute
Methodology of most of the published studies is diarrhoea. Arch Dis Child 1997;77: 196-200.
questionable in addition to them being sponsored 9. Dutta P, Mitra U, Datta A, Niyogi SK, Dutta S, Manna
by the drug company. More importantly all results B et al. Impact of zinc supplementation in
are not made available after another large malnourished children with acute diarrhoea. J Trop
multicentre study evaluating efficacy and safety of Pediatr 2000; 46: 259-263.
the same drug(15). 10. Baqui AH, Black RE, El Arifeen S, Yunus M,
Chakraborty J, Ahmed S et al. Effect of zinc
Acknowledgement supplementation started during diarrhoea on morbidity
and mortality in Bangladeshi children: Community
We acknowledge UNICEF for the scientific randomized trial. BMJ 2002;325(7372):1059.
grant for the meeting.
11. Effect of zinc supplementation on clinical course of
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Annexure

Members of the Task Force

Advisers: M.K. Bhan, H.P.S. Sachdev
Chairperson: Nitin Shah
Conveners: Shinjini Bhatnagar, Panna Choudhury
Co-convener: Rakesh Lodha
Members: Naveen Thacker, Raju Shah, Deepak Ugra, S.C. Arya, Shiela Aiyer, Seema Alam
Tarun Gera, Surjit Singh, Ajay Gaur, Siddhartha Gogia, Keya Kunnikel, Preeti Makhia
Jitender Nagpal, G.B. Nanda, Sushma Narayan, Sangita Subudhi, Nitya Wadhwa
UNICEF: K. Suresh, Anjana Gulani, Yogesh Jain, Asish Sen, Gaurav Arya, Raman Atkuri,
Sherin Varkey
WHO: Harish Kumar

INDIAN PEDIATRICS 389 VOLUME 44__MAY 17, 2007