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CTRI Number  CTRI/2024/01/061278 [Registered on: 09/01/2024] Trial Registered Prospectively
Last Modified On: 07/03/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study to evaluate the beneficial effects of probiotics by supplementing with standard of care in the treatment of diarrhea affecting infants and children with mild to moderate dehydration. 
Scientific Title of Study   To evaluate the efficacy of probiotic supplements for infants and children in the management of acute diarrhea in a tertiary care hospital in South India 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Elavarasi R 
Designation  Post Graduate 
Affiliation  CHENGALPATTU MEDICAL COLLEGE 
Address  Department of Pharmacology, Chengalpattu Medical College, VOC Nagar,Chengalpattu. Kancheepuram.

Kancheepuram
TAMIL NADU
603001
India 
Phone  7418446238  
Fax    
Email  maildrela@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr K Vijayarani 
Designation  PROFESSOR AND HOD 
Affiliation  CHENGALPATTU MEDICAL COLLEGE 
Address  Department of Pharmacology, Chengalpattu Medical College, VOC Nagar,Chengalpattu. Kancheepuram.

Kancheepuram
TAMIL NADU
603001
India 
Phone  9444728805  
Fax    
Email  vijayapaed@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Elavarasi R 
Designation  Post Graduate 
Affiliation  CHENGALPATTU MEDICAL COLLEGE 
Address  Department of Pharmacology, Chengalpattu Medical College, VOC Nagar,Chengalpattu. Kancheepuram.

Kancheepuram
TAMIL NADU
603001
India 
Phone  7418446238  
Fax    
Email  maildrela@gmail.com  
 
Source of Monetary or Material Support  
Tablets India Limited, 4th floor,JHAVER Centres,R.A Building, 72 Marshalls road,Chennai-600008 
 
Primary Sponsor  
Name  JHAVER Research Foundation 
Address  4th floor,JHAVER Centres,R.A Building, 72 Marshalls road,Chennai-600008 
Type of Sponsor  Research institution 
 
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 Elavarasi R  Chengalpattu Medical College and Hospital  Paediatric OPD, Chengalpattu Medical College and Hospital,GST road,Chengalpattu. 603001
Kancheepuram
TAMIL NADU 		 7418446238

maildrela@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,CHENGALPATTU MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K639||Disease of intestine, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Probiotic supplement Contains Bacillus mesentericus T-OA -1 Million Lactobacillus sporogenes - 50 Million, Streptococcus Thermophilus St-21- 100 Million, Bacillus Clausii - 2 Billion.   1 sachet of probiotic powder mixing in 10ml of water twice a day and oral rehydration solution for 5 days + syrup Zinc 20mg/ day for 14 days 
Comparator Agent  Standard of care for diarrhea  Oral rehydration solution for 5 days and syrup Zinc 20mg/day for 14 days 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  Children of either sex aged 6 months to 5 years suffering from acute diarrhea with moderate dehydration (duration < 3days)
 
 
ExclusionCriteria 
Details  Children with history of malabsorption syndromes.
Having respiratory infections / systemic infection.
Children with hypersensitivity to any of the components
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Measure of
Number of episodes (frequency) of diarrhea in a day
Mean duration of diarrhea (in days)
Duration and volume of oral rehydration salt [ORS] therapy
Duration and volume of intravenous fluid [IVF] therapy
Consistency of stool by Bristol stool scale.
 		 5 days study period 
 
Secondary Outcome  
Outcome  TimePoints 
secondary outcome will be assessed by the occurrence of adverse events (if worsening of existing symptoms, hypersensitivity reactions) following the administration of probiotics and if any will be notified to the IPC and will be uploaded in Vigiflow.
Parental satisfaction on a Likert scale through parental interviews after examining their daily records will be maintained in the diary 		 5 days study period 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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)   13/01/2024 
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="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Other (Terminated) 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

The study titled “ To evaluate the efficacy of probiotics supplements for infants and children in the management of acute diarrhea in a tertiary care hospital in south India” is Terminated and recruitment not done.

Reason: The sponsor insisted on sharing of raw data for publication which can promote the product (which turns it as regulatory trial). The IEC Chengalpattu medical college is registered for conducting of Academic trials only.

 
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