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CTRI Number  CTRI/2018/06/014480 [Registered on: 08/06/2018] Trial Registered Prospectively
Last Modified On: 09/03/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A multicentric, randomised, placebo controlled double blind study to compare safety and tolerability of Saccharomyces boulardii in acute diarrhoea 
Scientific Title of Study   A Multicentric, Randomized, Double Blind, Placebo Controlled Trial to assess the Efficacy and Safety of Saccharomyces Boulardii CNCM-I 3799 Bacillus Subtilis CU – 1 combination For treatment of Acute Diarrhoea in Indian Children 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis, Unit No. 10/5, 10th Floor, 1858/1, Rajdanga Main Road, Kolkata

Kolkata
WEST BENGAL
700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis, Unit No. 10/5, 10th Floor, 1858/1, Rajdanga Main Road, Kolkata

Kolkata
WEST BENGAL
700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Monjori Mitra 
Designation  Research Director 
Affiliation  Medclin Research Pvt. Ltd. 
Address  Medclin Research Pvt. Ltd. Acropolis, Unit No. 10/5, 10th Floor, 1858/1, Rajdanga Main Road, Kolkata

Kolkata
WEST BENGAL
700107
India 
Phone  9831075734  
Fax    
Email  monjorimr@gmail.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited 
 
Primary Sponsor  
Name  Alkem Laboratories Limited 
Address  Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai- 400013  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sushant Mane  Grant Government Medical college and Sir J J Group of Hospitals  Byculla, Mumbai - 400008 Phone: 9702658822
Mumbai
MAHARASHTRA 		 9820864049

drsush2006@gmail.com 
Dr Apurba Ghosh  Institute of Child Health   11, Dr. Biresh Guha Street Kolkata
Kolkata
WEST BENGAL 		 9830052887
03322905686
apurbaghosh@yahoo.com 
Dr Nirmala Dheivamani  Institute of Child Health and Hospital for Children  Halls Road, Egmore, Chennai, Tamil Nadu 600008
Chennai
TAMIL NADU 		 9840151024

nirmalanatarajan89@gmail.com 
Dr S Balasubramanian  Kanchi Kamakoti Childs Trust Hospital.  12 A, Nageshwara Road, Nungambakkam, Chennai – 600034
Chennai
TAMIL NADU 		 9840218954
914428259633
sbsped@gmail.com 
Dr Nimain C Mohanty  MGM Medical College  Dept of Paediatrics MGM Medical College, Plot No. 1, Sector-1, Kamothe, Navi Mumbai- 410209, Dist- Raigarh, Maharashtra
Raigarh
MAHARASHTRA 		 9920410522
022-27431092
nimain.mohanty@gmail.com 
Dr Piyali Bhattacharya  Sanjay Gandhi Post Graduate Institute of Medical sciences  Raebareli Road Lucknow-226014
Lucknow
UTTAR PRADESH 		 9415104073
05222668017
drpiyali@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
institutional Ethics Committee, Grant Government Medical College, Mumbai  Approved 
Institutional ethics committee,Institute of child Health   Approved 
Institutional Ethics Committee,Madras Medical College,Chennai  Approved 
Institutional Ethics Committee,MGM Institute of Health Sciences  Approved 
Institutional ethics committee,Sanjay Gandhi Postgraduate Institute of Medical Sciences  Approved 
Institutional Review Board Ethics committee of Kanchi Kamakoti CHILDS Trust Hospital and the CHILDS Trust Medical Research Foundation  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Acute Diarrhoea, (1) ICD-10 Condition: R197||Diarrhea, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Gutgain  Probiotic containing the yeast Saccharomyces Boulardii and the bacteria Bacillus subtilis 
Comparator Agent  Placebo  Identical looking Placebo having similar excipients as the study product but without the active pharmaceutical ingredient. 
 
Inclusion Criteria  
Age From  6.00 Month(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1. Subjects aged between 6 months - 5 years of either gender presenting with acute diarrhea of ≤ 72 hours duration without history of intake of any antibiotic and without dehydration or with features of mild or moderate dehydration.
2. Parent or legal guardian of the subjects /subject must give written informed consent for study participation.
3. Parent of the subjects must follow all instructions as per the protocol
 
 
ExclusionCriteria 
Details  1. Subjects with clinical signs of dysentery, severe dehydration requiring hospitalization or parenteral fluid therapy.
2. Intake of any systemic antibiotic or any anti-diarrheal medication, in the previous 3 weeks prior to screening
3. Subjects who are debilitated or seriously ill or immunocompromised.
4. Subjects with symptoms or suspicion of an organic lesion of the digestive tract, or with undiagnosed abdominal pain or rectal bleeding or other GI disorder especially ulcerative colitis, Crohn’s disease, history of carcinomas of the bowel, malabsorption syndrome, intolerance to certain food types (lactose), functional diarrhea and functional constipation.
5. Use of probiotics in the last 3 weeks prior to baseline visit.
6. Current use of any drugs or treatments which is supposed to decrease the gastrointestinal motility or any other concomitant anti-diarrheal medication.
7. Subjects who have undergone ileostomy, jejunostomy or colostomy
8. Subjects with hypersensitivity to any ingredient in the formulation.
9. Subjects with coexisting features of acute systemic disease like septicemia, meningitis, pneumonia etc. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
Duration of diarrhea will be computed as time in hours after study product administration to the last abnormal (loose or liquid) stool preceding a normal stool output and the same would also be computed during the study period. Stool frequency will be noted as number of times the subject passes stool every day. Stool consistency will be evaluated on a 4 point Likert scale: 1- normal, 2- Loose, 3- semi-solid, 4 – liquid.   5 days 
 
Secondary Outcome  
Outcome  TimePoints 
The assessment of the safety of the study medications will be evaluated by monitoring of both serious (SAE) and non-serious solicited and unsolicited adverse events during the study period. Assessment of tolerability will be done by the physician on a 4 point Likert Scale 1- excellent, 2- good, 3- fair, 4- poor.  5 days 
Subjects in both groups will be followed up 3 months post intervention to compare the incidence of acute diarrheal episodes between the test and placebo group.  3 months 
 
Target Sample Size   Total Sample Size="180"
Sample Size from India="180" 
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)   20/06/2018 
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="5"
Days="29" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   The findings of this study may be published in a scientific journal or presented at a scientific meeting with prior permission from ALKEM Laboratories. The sponsor and the CRO, reserves the right to review all manuscripts prior to submission for publication or any paper before it is presented. In accordance with standard editorial and ethical practice, the sponsor and the CRO will generally support publication of multicentric trials only in their entirety and not as individual center data. Authorship will be determined by mutual agreement between the sponsor in conjunction with the CRO and the Principal investigator(s).  
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The proposed clinical trial is to assess the efficacy of the probiotic saccharromyces boulardii in combination with the bacteria bacillus subtilis in reducing the duration and frequency of acute diarrhoea in children in the age group of 5 month to 6 years. The study is double arm, placebo controlled randomized prospective study. The study proposes to enroll a totral of 180 subjects from 4 sites and follow up the enrolled subjects 3 months post treatment period to assess the incidence of acute diarrhoea. The safety profile of the probiotic will also be assessed in terms of AEs. 
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