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CTRI Number  CTRI/2024/08/072125 [Registered on: 08/08/2024] Trial Registered Prospectively
Last Modified On: 13/09/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Nutraceutical 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A study to evaluate the efficacy of probiotic formulation in improving antibiotic associated diarrhoea in children. 
Scientific Title of Study   A double blind, placebo-controlled, randomized, parallel-group study to evaluate the efficacy of probiotic formulation in amelioration of antibiotic associated diarrhoea in children. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
LCBS-UB-134, Version 1.0 dated 02 May 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rohith H R 
Designation  Professor 
Affiliation  BGS Global Institute of Medical Sciences 
Address  Department of Paediatrics, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri

Bangalore
KARNATAKA
560060
India 
Phone  9741073960  
Fax    
Email  drrohith.research@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jestin V Thomas 
Designation  Director 
Affiliation  Leads Clinical Research and Bio Services Pvt. Ltd 
Address  No.9, Mythri Legacy, Kalyan Nagar, Chelekere Main Road

Bangalore
KARNATAKA
560043
India 
Phone  9845125293  
Fax    
Email  jestin.leadsclinbio@gmail.com  
 
Source of Monetary or Material Support  
Unique Biotech Ltd. Plot no.2, Phase-II, M.N. Park, Kolthur village, Shameerpet mandal, Medchal Malkajgiri dist Hyderabad, Telangana, 500 101, India 
 
Primary Sponsor  
Name  Unique Biotech Ltd. 
Address  Plot no.2, Phase-II, M.N. Park, Kolthur village, Shameerpet mandal, Medchal Malkajgiri dist Hyderabad, Telangana, 500 101, India 
Type of Sponsor  Other [Manufacturer of natural plant based food ingredients and Nutraceutical ingredients] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Rohith HR  BGS Global Institute of Medical Sciences  Room No.04, Ground Floor, Department of Paediatrics, No.67, BGS Health and Education City, Uttarahalli Road, Kengeri Bangalore
Bangalore
KARNATAKA 		 974103960

drrohith.research@gmail.com 
Dr Hetal Vora  Smt.SCL General Hospital (Sharadaben Hospital)  Room No.05, Department of Paediatrics, Saraspur
Ahmadabad
GUJARAT 		 9925011369

drhetalvoranm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Institutional Ethics Committee, BGS Global Institute of Medial Sciences  Approved 
Institutional Ethics Committee, NHLIEC  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K528||Other specified noninfective gastroenteritis and colitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BACIPRO vials  Bacillus clausii UBBC-07 suspension in water (2x10 riased to 9 CFU per 5ml vial) in 5 ml twice a day 
Comparator Agent  Placebo  RO water in 5 ml twice a day  
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Outpatients with a proven or suspected infection anticipated to be treated on physicians prescribed amoxicillin+ clavulanate or other combinations with amoxicillin.Willing to give written informed consent/assent 
 
ExclusionCriteria 
Details  1.Subject with history of
o Prior use of antibiotics within the previous 6 weeks.
o Presence of a severe or generalised infection.
o Severe chronic disease.
o Pre-existing diarrhoea within the previous 4 weeks.

2.Patients with bloody or purulent stool, with pus or mucus.

3.Severe dehydration needing hospitalization.

4.Infants on exclusive breastfeeding

5.Requiring hospitalization

6.An axillary temperature greater than 38.2°C or an oral temperature greter than 38.6°C.

7.Symptoms of septicaemia

8.Subjects having hypersensitivity or history of allergy to any component of the study product.

9. Unable to take medication orally or tolerate oral rehydration.

10.Taken probiotics prior to study (2 months) or during study other than interventional product.

11.History of gastric ulcer, duodenal ulcer, combined gastric and duodenal ulcers, upper gastrointestinal bleeding, autoimmune gastritis and GERD.

12.Use of any proton pump inhibitor, sucralfate, H2-receptor antagonist, or bismuth preparations or any muscarine receptor antagonist and gastrin receptor antagonist within 2 weeks before initiating study IP therapy.

13.History of intubations for co-morbidities like, chronic lung disease (CLD), congenital heart defects (CHD) or neurologic disorders.

14.Use of any other investigational drug currently or within 30 days prior to study entry.

15.Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.

16.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Change in the incidence of antibiotic-associated diarrhoea assessed in the investigational product arm compared to placebo.  Day 1, Day 7, Day 15 and Day 30 
 
Secondary Outcome  
Outcome  TimePoints 
Change in the efficacy parameters assessed in the investigational product arm compared to placebo at a defined time points in comparison to baseline  Day 1, Day 7, Day 15 and Day 30 
Fecal microbiota analysis  Day 1 and Day 30 
 
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 3/ Phase 4 
Date of First Enrollment (India)   19/08/2024 
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)  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   This is a double blind, randomized, placebo controlled, two-arms, parallel group study. 300 infants or children meeting all eligibility criteria would be screened in the study after obtaining written informed consent from parents or guardians. The eligible subjects will be randomized into one of the 2 treatment arms to receive either the treatment arm or placebo twice a day. Probiotic or Placebo suspension will be continued for one week after cessation of antibiotic treatment. Clinical assessments will be performed as per the protocol. Details of antibiotic associated diarrhoea will be assessed using questionnaires. A diary will be provided to record the study IP administration, details of diarrhoea, side effects, hospital stay, rescue medication, and concomitant medication details during the study duration.  
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