1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response -  Analytic Code
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - Any purpose.
   


5. By what mechanism will data be made available?
   Response (Others) - 


6. For how long will this data be available start date provided 21-05-2021 and end date provided 21-10-2025?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - None

Acute gastroenteritis is an infectious syndrome that represents the first cause of hospitalization in children¹.Diarrhea is usually a symptom of an infection in the intestinal tract, which can be caused by a variety of bacterial, viral and parasitic organisms. Infection is spread through contaminated food or drinking water, or from person-to-person as a result of poor hygiene². Diarrhea due to infection is widespread throughout developing countries. In developing countries, children under 5 years of age experience on average three episodes of diarrhea every year³.One out of every five children who die of diarrhea worldwide is an Indian. Repeated episodes of diarrhea in children can result in long-term deleterious effects on nutritional status, possibly due to intestinal damage. Each episode deprives the child from the basic nutrition necessary for growth. As a result, diarrhea is a major cause ofmalnutrition, and malnourished children are more likely to fall ill from diarrhea².The management of acute diarrhoea consists of the replacement of lost fluid with glucose-electrolyte oral rehydration solution. This solution, however, reduces neither the severity nor the duration of diarrhoea⁴ but has substantial benefit in preventing major morbidities due to dehydration and even mortality. The need of the hour is such agents which reduces both severity and duration of diarrhoea without any major impact on the motility retardation.

Probiotics are live microbial feed supplements that beneficially affect the host by improving its microbial balance. They are commonly used in the treatment and prevention of acute diarrhea. The rationale for using probiotics in acute infectious diarrhea is based on the assumption that they act against intestinal pathogens⁵ through a variety of physiological and mechanical hostility to pathogens.

Out of many probiotics available, Bacillus Clausii is found to be beneficial in reducing prevalence, duration and severity of diarrhea⁶. This study is aimed to evaluate efficacy of Bacillus Clausii in treatment of acute diarrhea in children.