| CTRI Number |
CTRI/2025/10/096646 [Registered on: 30/10/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of Effectiveness Between Various Probiotics in Children With Acute Watery Diarrhoea |
|
Scientific Title of Study
|
Comparison of Effectiveness between Saccharomyces Boulardii, Bacillus Clausii and LacticAcid bacillus in Children With Acute Watery Diarrhoea - A Randomized, parallel group, Multiple Arm Trial. |
| 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 Suresh R |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics, SRM Medical College Hospital and Research Centre, Kattankulathur,
Chengalpattu
SRM Nagar, Potheri, Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
9940403011 |
| Fax |
|
| Email |
surmbbs@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abirami R |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics, SRM Medical College Hospital and Research Centre, Kattankulathur,
Chengalpattu
SRM Nagar, Potheri, Kattankulathur,
Chengalpattu
Chennai
TAMIL NADU
603203
India |
| Phone |
9884835001 |
| Fax |
|
| Email |
abiramiraju65@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Suresh R |
| Designation |
Associate Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Department of paediatrics, SRM Medical College Hospital and Research Centre, Kattankulathur,
Chengalpattu
SRM Nagar, Potheri, Kattankulathur,
Chengalpattu
TAMIL NADU
603203
India |
| Phone |
9940403011 |
| Fax |
|
| Email |
surmbbs@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Suresh R |
| Address |
Associate Professor, Department of Paediatrics, SRM Medical College Hospital & Research Centre, S.R.M Nagar, Potheri, Kattankulathur, Chengalpattu - 603203, Tamilnadu, India. |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr R Suresh |
SRM Medical College Hospital and Research Centre |
Room No : 14, C Block, Department of Paediatrics, S.R.M Nagar, Potheri, Kattankulathur, Chengalpattu-603203, Tamilnadu, India.
Chennai
TAMIL NADU
Chennai
TAMIL NADU |
9940403011
surmbbs@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SRM Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A09||Infectious gastroenteritis and colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus clausii |
Bacillus clausii, one sachet containing 2 billion spores, once daily until recovery along with routine standard treatment |
| Intervention |
Lactic acid bacillus |
Lactic acid bacillus, given as one sachet daily containing 50 million spores, until recovery along with routine standard treatment |
| Comparator Agent |
Oral Rehydration Solution |
Oral Rehydration Solution along with Zinc as routine standard treatment until recovery |
| Intervention |
Saccharomyces boulardii |
Saccharomyces boulardii, given as one sachet containing 2.5 billion spores, once daily until recovery along with routine standard treatment |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
14.00 Year(s) |
| Gender |
Both |
| Details |
All children presenting with acute watery diarrhoea from 6 Months to 14 years of age and whose parents give valid consent for the study
|
|
| ExclusionCriteria |
| Details |
Children presenting with Blood in stools
Children presenting with features of colitis
Children with Malabsorption
Children with chronic diarrhea
Children with Persistent diarrhea
Children with Immunodeficiency
Children whose parents refuse to give consent for the study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To Compare the effectiveness between Saccharomyces boulardii, Bacillus clausii, lactic acid bacillus and Routine standard treatment(ORS with Zinc) in decreasing the frequency and Duration of diarrhea
|
At the time of recovery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
08/11/2025 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Probiotics
are living microorganisms, when ingested in sufficient large amount confer a
health benefit on the host. There is evidence that selected strains of
probiotics decrease the duration of acute diarrhea. There
are many probiotics that are available to be used in children but the
effectiveness of this probiotic are still not proven
Hence
there is a need for a Randomised
study to compare the effectiveness between three major probiotics such as Saccharomyces
boulardii,
Bacillus clausii and
lactic acid bacillus |