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CTRI Number  CTRI/2025/07/090652 [Registered on: 10/07/2025] Trial Registered Prospectively
Last Modified On: 10/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparing Synbiotics and Probiotics for Treating Diarrhea in Hospitalized Children: A 12-Day Study on Safety and Effectiveness 
Scientific Title of Study   "Comparison of efficacy and safety of synbiotic versus probiotic in the treatment of acute gastroenteritis in hospitalised children: A prospective, randomized, open-label, 12-day study." 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vinesh choudhary 
Designation  Junior Resident 
Affiliation  Indira Gandhi Government Medical College 
Address  Department of Pharmacology Indira Gandhi Government Medical College, Nagpur

Nagpur
MAHARASHTRA
440018
India 
Phone  9389695542  
Fax    
Email  vineshchoudhary431@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Vandana Avinash Badar 
Designation  Professor and Head of The Department 
Affiliation  Indira Gandhi Government Medical College, Nagpur 
Address  Department of Pharmacology Indira Gandhi Government Medical College, Nagpur

Nagpur
MAHARASHTRA
440018
India 
Phone  9960031486  
Fax    
Email  drvandanabadar@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Vandana Avinash Badar 
Designation  Professor and Head of The Department 
Affiliation  Indira Gandhi Government Medical College, Nagpur 
Address  Department of Pharmacology Indira Gandhi Government Medical College, Nagpur

Nagpur
MAHARASHTRA
440018
India 
Phone  9960031486  
Fax    
Email  drvandanabadar@yahoo.co.in  
 
Source of Monetary or Material Support  
Indira Gandhi Government Medical college, Nagpur, Maharashtra, India Pincode- 440018 
 
Primary Sponsor  
Name  Vinesh Choudhary 
Address  Indira Gandhi Government Medical College, Nagpur, Maharashtra, India Pincode- 247667 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Vinesh Choudhary  Indira Gandhi Government Medical College  Department of Pharmacology Indira Gandhi Government Medical College, Nagpur, Maharasthra Pincode- 440018
Nagpur
MAHARASHTRA 		 09389695542

vineshchoudhary431@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, IGGMC, Nagpur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Bacillus Clausii Spores (2 billion spores) oral Suspension 5ml   Bacillus Clausii Spores (2 billion spores) oral Suspension 5ml will be given twice a day in for 5 days 
Intervention  Probiotic (blend of lactobacillus Acidophillus, Lactobacillus Rhamnosus, Bifidobacterium Longum, Sacchromyces Boulardi)  Probiotic (blend of lactobacillus Acidophillus, Lactobacillus Rhamnosus, Bifidobacterium Longum, Sacchromyces Boulardi) 1g containing 1.25 billion cells twice daily 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children with acute diarrhea admitted to in patient department & showing signs of dehydration (less than 14 days duration)

Parents willing to give written informed consent
 
 
ExclusionCriteria 
Details  1. Children with persistent/chronic diarrhea
2. Children with severe malnutrition
3. Children having respiratory/systemic infection
4. Subjects who participated in any investigational drug within 30 days prior to study screening
5. Children with known hypersensitivity for synbiotic or probiotics
6. Children with chronic systemic illness
7. Parents not willing to give written inform consent
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
compare the reduction in frequency and duration of diarrhea after administration of synbiotic and probiotic  0, 5th and 12th day 
 
Secondary Outcome  
Outcome  TimePoints 
1) To assess the effects on consistency of stool
2) To evaluate adverse drug reactions of Synbiotic and Probiotic
 		 1) To assess the effects on consistency of stool
2) To evaluate adverse drug reactions of Synbiotic and Probiotic
on 0, 5th and 12th day 
 
Target Sample Size   Total Sample Size="166"
Sample Size from India="166" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/09/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="6"
Days="1" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [vineshchoudhary431@gmail.com].

  6. For how long will this data be available start date provided 01-01-2027 and end date provided 01-12-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

This prospective, randomized, open-label study aims to compare the efficacy, safety, and tolerability of synbiotics versus probiotics as adjunctive therapy in children aged 6 months to 12 years hospitalized with acute gastroenteritis. Diarrheal illness is a significant cause of morbidity and mortality among young children. Although probiotics have shown moderate benefits in reducing diarrhea duration, synbiotics—combinations of probiotics and prebiotics—are thought to have superior effects by enhancing gut microflora, improving immunity, and reducing inflammation.

 

The study will enroll 166 children divided into two groups: one receiving synbiotics with standard therapy and the other probiotics with standard therapy (oral rehydration and zinc supplementation). Primary objectives include comparing reductions in diarrhea frequency and duration, with secondary assessment of stool consistency and adverse effects. Data will be analyzed statistically, and ethical guidelines will be strictly followed.

 

The study expects that synbiotics will result in faster recovery and better outcomes than probiotics alone, potentially offering an effective strategy for managing acute gastroenteritis in children. 
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