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CTRI Number  CTRI/2021/03/031870 [Registered on: 10/03/2021] Trial Registered Prospectively
Last Modified On: 09/03/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Probiotic 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   A Study to Evaluate the Efficacy of Supplementation with Bacillus Coagulans SNZ 1969 In Reducing Infection in Malnourished Children and To Evaluate Its Safety 
Scientific Title of Study   A Randomized, Double Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy of Supplementation with Bacillus Coagulans SNZ 1969 In Reducing Infection in Malnourished Children and To Evaluate Its Safety 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Madeline Janice Fernandes 
Designation  Post Graduate Student 
Affiliation  Byramjee jheejheeboy government medical college 
Address  Department of Pharmacology B.J. Govt. Medical College and Sassoon General Hospitals Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001

Pune
MAHARASHTRA
411001
India 
Phone  9711078113  
Fax    
Email  maddiefern3@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Bharti R Daswani 
Designation  Professor 
Affiliation  Byramjee jheejheeboy government medical college 
Address  Department of Pharmacology B.J. Govt. Medical College and Sassoon General Hospitals Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001

Pune
MAHARASHTRA
411001
India 
Phone  9421965337  
Fax    
Email  daswani_bharti@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Madeline Janice Fernandes 
Designation  Post Graduate Student 
Affiliation  Byramjee jheejheeboy government medical college 
Address  Department of Pharmacology B.J. Govt. Medical College and Sassoon General Hospitals Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001

Pune
MAHARASHTRA
411001
India 
Phone  9711078113  
Fax    
Email  maddiefern3@gmail.com  
 
Source of Monetary or Material Support  
Byramjee. Jeejeebhoy Government medical college and Sasoon hospital 
 
Primary Sponsor  
Name  Madeline J Fernandes 
Address  Department of Pharmacology B.J. Govt. Medical College and Sassoon General Hospitals Jai Prakash Narayan Road, Near Pune Railway Station, Pune - 411001 
Type of Sponsor  Other [Self] 
 
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 Madeline J Fernandes  BJGMC and sassoon hospital  Pediatric Department opd no 29, 30 first floor
Pune
MAHARASHTRA 		 9711078113

maddiefern3@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE BJ Govt MEDICAL COLLEGE SASSOON GENERAL HOSPITALS PUNE   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E40-E46||Malnutrition,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  PLACEBO  ARM B will receive Matching Placebo which contain pharma grade sugar, lactose (in minute quantity), flavoring agents and stabilizers without bacillus coagulans 5ml TDS in double blind randomized fashion for a duration of 3 months 
Intervention  SPORLAC SYRUP  ARM A will receive syrup which contain 300 million CFU of bacillus coagulans per 5ml TDS in double blind randomized fashion for a duration of 3 months. 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  5.00 Year(s)
Gender  Both 
Details  1.Age 1-5years
2.Evidence of moderate malnutrition (having a weight-for-height z-score of -3.0 to less than -2.0)
 
 
ExclusionCriteria 
Details  1.Age <1yr or >5yrs,
2.History suggestive of Chronic inflammatory bowel diseases,
3.Immunocompromised /HIV positive.
4.Any evidence of Malignancy.
5.History and clinical findings suggestive of Metabolic diseases
6.History and clinical findings suggestive of Chronic respiratory tract diseases including respiratory allergies and cystic fibrosis.
7.Malformations of gastrointestinal or urinary or respiratory tract on clinical or radiological findings.
8.History of respiratory or gastrointestinal or urinary tract surgery.
9.History and Clinical findings suggestive of Congenital cardiac defects.
10.History suggestive of challenge-proved food allergy and Food intolerance.
11.Normal nourished (-1 12.History of use of antibiotics or pre/pro/symbiotic or immune stimulating products in the 2 weeks before the enrolment.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90  Number of episodes of gastrointestinal or respiratory tract infections during the period from day 0 to day 90 
 
Secondary Outcome  
Outcome  TimePoints 
Number of children experiencing at least one episode of AGI or RTI in 30 days  day 0 to day 90 
Number of children experiencing at least one episode of AGI or RTI in 60 days  day 0 to day 90 
Number of children experiencing at least one episode of AGI or RTI in 90 days  day 0 to day 90 
Number of children with vomiting episodes  day 0 to day 90 
Number of children with diarrheal episodes  day 0 to day 90 
Number of gastrointestinal infections lasting longer than 2 days  day 0 to day 90 
Number of children with upper respiratory tract infection, including rhinitis, pharyngitis, sinusitis, otitis, and the common cold  day 0 to day 90 
Number of children with lower respiratory tract infections, including pneumonia, bronchitis, and bronchiolitis  day o to day 90 
Number of respiratory tract infections lasting longer than 3 days.  day 0 to day 90 
Number of severe diarrhea episodes.  day o to day 90 
Total days of illness  day 0 to day 90 
Total Number of Days with respiratory and gastrointestinal Symptoms  day o to day 90 
Emergency Department Medical visit if child has symptoms of gastrointestinal and respiratory tract infection  day o to day 90 
Number of days of work lost by the parents  day 0 to day 90 
Number of days of preschool lost by children  day o to day 90 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/03/2021 
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="9"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary   PROBIOTICS
Many studies are trying to evaluate the benefits of correction of gut flora to improve immunity and growth parameters of children. One such method is by administration of probiotics.   The World Health Organization defines probiotics as Live microorganisms which when administered in adequate amounts confer a health benefit on the host.

A study of Lactobacillus acidophilus conducted on malnourished children in India found that it can cause an increment of weight and height in relation of placebo. They also observed lower frequency of diarrhea and fever episodes in this group than in controls.

  However apart from lactobacillus acidophilus there are other species of lactobacillus which are being marketed as a probiotic. One such probiotic is Bacillus Coagulans, which was initially described as lactobacillus sporogeneses. 

 It seems worthwhile to study effects of Bacillus coagulans on risk of gastrointestinal and upper respiratory tract infection in the at-risk population


MALNUTRITION:

      Malnutrition is one of the major health problems and is associated with recurrent infections especially in gastrointestinal and respiratory tracts and also leads to some defects in weight, height, cognitive functions, and behavior..

HYPOTHESIS:

       Therefore, we have designed this study to evaluate if administration of Bacillus coagulans SNZ 1969 has any role in reducing infections in malnourished children and improving the wellbeing of the children.

 
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