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CTRI Number  CTRI/2025/03/081891 [Registered on: 07/03/2025] Trial Registered Prospectively
Last Modified On: 06/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study designed to assess the how safe and effective Sporolac in treatment of acute diarrhea in paediatric population. 
Scientific Title of Study   A prospective, randomized, multicenter, parallel-group clinical study evaluating the efficacy and safety of Sporlac in the management of acute diarrhea. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
JB-25-02 Version 01 Dated 05 Feb 2025  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Jayesh Sanmukhani 
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297/301, SoBo Center, South Bopal, ahmedabad.

Ahmadabad
GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Jayesh Sanmukhani 
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297/301, SoBo Center, South Bopal, ahmedabad.


GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Details of Contact Person
Public Query  
Name  Dr Jayesh Sanmukhani 
Designation  Head – Medical Services 
Affiliation  Clinexcel Research 
Address  297/301, SoBo Center, South Bopal, ahmedabad.


GUJARAT
380058
India 
Phone  7600012192  
Fax    
Email  drjayesh@clinexcelresearch.com  
 
Source of Monetary or Material Support  
J. B. chemicals & pharmaceuticals LTD., Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025 
 
Primary Sponsor  
Name  J. B. chemicals & pharmaceuticals LTD. 
Address  Cnergy IT Park, Unit A2, 3rd floor & Unit A, 8th floor, Appa Saheb Marathe Marg, Prabhadevi, Mumbai 400025  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shreyans Shah  Aatman Hospital  Basement , Clinical Research Department, 5, Anveshan Row House, Opp Umiya Mata Mandir Bopal - Ghuma Main Road, Bopal Ghuma Ahmedabad - 380058, India
Ahmadabad
GUJARAT 		 919909977831

shreyans200@yahoo.com  
Dr Chinmayi Joshi  Belgaum Institute Of Medical Sciences  Ground Floor, Clinical Research Room, Dr B R Ambedkar Rd, Sadashiv Nagar, Belagavi, Karnataka 590019
Belgaum
KARNATAKA 		 9535692258

Bimsclinicalresearch@gmail.com 
Dr Upendra Kinjawadekar  Kamalesh Mother and Child hospital   Clinical Research Room, Ambika Shopping Centre, Sector 8, Nerul, Navi Mumbai, Maharashtra 400706
Mumbai
MAHARASHTRA 		 9821186601

upen228@gmail.com 
Dr Rajitkumar Ray  KIDS Hospital  Clinical Research Room, 1120, Dumduma, Bhubaneswar, Odisha 751019
Khordha
ORISSA 		 9338089618

drrajib2007@gmail.com  
Dr Rehan Ansari  V.s.. General Hospital  Room No. 08, Burns Ward, 02nd Floor, Paldi, V.S.. Hospital, Paldi, Ahmedabad. 380006, Gujarat, India.
Ahmadabad
GUJARAT 		 9727262211

rehanansari78647@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 5  
Name of Committee  Approval Status 
Institutional Ethics Committee Aatman Hospital  Submittted/Under Review 
Institutional Ethics Committee, BIMS  Submittted/Under Review 
KIDS Ethics Committee  Submittted/Under Review 
Institutional Ethics Committee Aatman Hospital  Approved 
Institutional Ethics Committee Aatman Hospital  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R197||Diarrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Sporlac DS Tablet and Standard of Care   120 million spores of Lactic Acid Bacillus in more than 8 years to 18 years Twice daily from Day 1 to Day 5 
Intervention  Sporlac Powder and Standard of Care   150 million spores of Lactic Acid Bacillus in 6 months to 8 years Twice daily from Day 1 to Day 5 
Comparator Agent  Standard of Care  From Day 1 to Day 5. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1. Pediatric male and female patients aged 6 months to 18 years.
2. Patients diagnosed with acute diarrhea, characterized by the sudden onset of more than 3 loose or watery stools within 24 hours.
3. Parent of patient willing to provide written informed consent for their children.
4. Parent of patient (or their legal guardians, where applicable) willing to complete subject diaries and respond to study questionnaires, including daily documentation of stool frequency, stool consistency, and other efficacy parameters in diary card or willing to document all the details telephonically to CRC on daily basis.
5. Parent of patient with access to a functioning telephone for study-related communication.
6. Patients in generally good health, with no known significant underlying medical conditions that could interfere with study outcomes. 
 
ExclusionCriteria 
Details  1. Known hypersensitivity to Sporlac Powder/ DS Tablet or any component of the formulation.
2. Severe dehydration requiring hospitalization or any patient with symptoms of dehydration needing inpatient care at the time of study enrolment.
3. Patients currently on medications that may interact with Sporlac or those on concurrent medications that could interfere with the study outcomes or standard treatment for diarrhea.
4. Recent use of non-prescribed probiotic supplements or anti-diarrheal (including
products containing live cultures, such as yogurt) or antibiotics within the last seven
days for the treatment of diarrhea.
5. Patients with known significant uncontrolled medical conditions, including chronic
gastrointestinal disorders (except irritable bowel disease) or other systemic diseases.
6. Clinically significant signs or symptoms indicative of parasitic or bacterial diarrhea.
7. Current presence of blood, pus, or mucus in stools, or a history of these symptoms
within the previous 3 months.
8. Persistent diarrhea, defined as a duration exceeding 14 days.
9. Severe or persistent vomiting that may interfere with study participation or outcomes.
10. Participation in another clinical trial within the last 30 days.
11. Pregnant or breastfeeding women, or women of childbearing potential
12. Not willing to comply with the study requirements. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Stool frequency over treatment duration in the two groups.  At the end of treatment (Day 5) 
 
Secondary Outcome  
Outcome  TimePoints 
Stool consistency using Bristol stool scale over treatment duration in the two groups.  At the end of treatment (Day 5) 
Time to first formed stool after initiation of treatment  Baseline Vs End if Treatment (Day 5) 
Abdominal pain score using NRS (more than 8 years) or over treatment duration in the two
groups. 		 Baseline Vs End of Treatment (Day 5) 
Presence or absence of other associated abdominal symptoms during treatment period  Baseline Vs End of Treatment (Day 5) 
Adverse events reported during the study  At the End of Study (Day 5) 
Serious adverse events reported during the study  At the End of Study (Day 5) 
 
Target Sample Size   Total Sample Size="300"
Sample Size from India="300" 
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)   17/03/2025 
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="0" 
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 - NO
Brief Summary  
In this study, pediatric patients aged 6 months to 18 years diagnosed with acute diarrhea, characterized by the sudden onset of more than 3 loose or watery stools within 24 hours, will be screened and enrolled if found eligible at Assessment 1 (Initiation of treatment – Day 0). All enrolled patients will undergo an in-person follow-up at Assessment 2 (End of the treatment - Day 5). A total of 300 pediatric patients with acute diarrhea in India will be enrolled in this clinical trial to evaluate the efficacy and safety of Sporlac in management of acute diarrhea. This is a two arm study, with subjects randomized to receive either Test treatment (Sporlac + SOC) or Reference treatment (SOC). Primary objective of study is to evaluate the efficacy of Sporlac in the management of acute diarrhea. Secondary objective is to assess the safety of Sporlac in the management of acute diarrhea. 
 
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