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CTRI Number  CTRI/2020/07/026720 [Registered on: 21/07/2020] Trial Registered Prospectively
Last Modified On: 20/07/2020
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 controlled parallel-group clinical study to assess the effects of a Bacillus coagulans-based product in patients with IBS-Diarrhea 
Scientific Title of Study   A prospective, randomized, double-blind, placebo-controlled parallel-group clinical trial to evaluate the effects of a Bacillus coagulans-based product in patients with IBS-Diarrhea 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
BIAG-CSP-034 Version No:1.0, Dated 30 March 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Rajanna M 
Designation  Consultant –Physician 
Affiliation  Arogyavardhini Ayurvedic Centre  
Address  Dr Rajanna M Consultant –Physician No:2, 5th Cross, Giddappa Layout, Kammanahalli, St Thomas Town Post, Bangalore-560084 Bangalore KARNATAKA

Bangalore
KARNATAKA
560084
India 
Phone  8660620501  
Fax    
Email  mdrrajanna@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Shalini Dayananda  
Designation  Associate Vice President 
Affiliation  Bio Agile Therapeutics Pvt. Ltd 
Address  #2/5, 3rd Floor Dahlia Building, 80 Feet road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  08043754520   
Fax    
Email  pm@bioagiletherapeutics.com  
 
Details of Contact Person
Public Query  
Name  Divya C 
Designation  CEO 
Affiliation  Bio Agile Therapeutics Pvt. Ltd 
Address  #2/5, 3rd Floor Dahlia Building, 80 Feet road, RMV 2nd Stage, Bangalore

Bangalore
KARNATAKA
560094
India 
Phone  9538961761  
Fax    
Email  divya@bioagiletherapeutics.com  
 
Source of Monetary or Material Support  
Abode Biotec India Private Limited Plot no: 34 A, Huda heights, 2nd floor, Road no:12 Banjara hills, near lotus pond, Telangana 500033. INDIA  
 
Primary Sponsor  
Name  Abode Biotec India Private Limited 
Address  Banjara hills, near lotus pond, Telangana 500033 
Type of Sponsor  Pharmaceutical industry-Indian 
 
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 Rajanna M  Arogyavardhini Ayurvedic Centre  No:2, 5th Cross, Giddappa Layout, Kammanahalli, St Thomas Town Post, Bangalore-560084 Bangalore KARNATAKA
Bangalore
KARNATAKA 		 8660620501

mdrrajanna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ACE Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Irritable Bowel Syndrome-Diarrhea 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Placebo  106-108 CFU in the form of powder to be reconstituted in water to be consumed in morning and evening (one each).  
Intervention  Probiotic containing B. coagulans   106-108 CFU in the form of powder to be reconstituted in water to be consumed in morning and evening (one each). 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female
2.18 - 65 years old
3.Signed informed consent
4.IBS-Diarrhea patient satisfying Rome III criteria.
o Recurrent abdominal pain or discomfort, 3 days per month in the last 3 months (12 weeks), associated with ≥ 2 of the criteria below. The criteria are fulfilled with symptoms onset 6 months prior to diagnosis: 
 
ExclusionCriteria 
Details  1. The patient will be excluded from the study if assessment by the treating investigator showed an evidence for cardiovascular, respiratory, urogenital, gastrointestinal/hepatic, hematologic/immunologic, head, ears, eyes, nose and throat, dermatologic/psychiatric, allergy, major surgery or other diseases as revealed by history, physical examination and existing laboratory assessments which may interfere with the administration.
2.Pregnant or lactating women.
3.Females at childbearing age will be excluded unless they are using acceptable birth control measures (i.e. implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices, sexual abstinence or a vasectomized partner).
4.Patients requiring treatments with non-permitted medication (i.e. 5-HT3 antagonist, spasmolytics, anticholinergics, cholestyramine, anti flatulence agents, metoclopramide, gastric-anti secretory agents (proton pump inhibitors; for indications other than Gastroesophageal Reflux Disease (GERD)), narcotics, anti-diarrheal drugs, and systemic steroids)
5.Patients requiring the use of antibiotics either in medicine form of natural (e.g. grapefruit seed extract, olive leaf extract, oil of oregano, colloidal silver and highly concentrated garlic preparations)
6. Exercise and the use of complementary and alternative medicine for IBS symptoms (i.e. peppermint oil, cognitive behavior therapy) during the study should be maintained at the same level prior to the study.
7.Patients exceeding the treatment limits of permitted medication [(more than 2 days/week during the study period): alginate, antacids and analgesics (limited to acetaminophen ≤ 1000 mg/day, acetylsalicylic acid or NSAIDS no more than 2 tablets/day), (stable dose throughout the study period, anti-depressants (must be on a stable dose > 3 months), fiber supplements, psyllium hydrophilic mucilloid, gastric anti secretory agents (only for GERD patients who are on a stable dose > 3 months; patients should be able to differentiate between IBS and GERD symptoms), acetylsalicylic acid ≤ 325 mg/day, sedatives. Deliverance medications: Mild laxatives only if necessary.]. Any other medications can be used without limits based on the clinical judgment of the treating investigator.
8.Being in another clinical trial 4 weeks before entering the study
9.Constipated IBS patients
10.IBS-Diarrhea patients with un-treated lactose intolerance
11.Regular use of probiotics or using other probiotics during the course of the study
12.Patients allergic to milk or soy products
13.Patients using catheters
14.Patients presented with rectal bleeding, weight loss, iron deficiency anemia, nocturnal symptoms and a family history of colorectal cancer, inflammatory bowel disease and celiac spruce
15.Patients over 50 diagnosed with Irritable Bowel Syndrome who have not had a colonoscopy in the last 5 years
16.Patients who have allergies for the active ingredients or any of the excipients
17.Patients presented with any immune-compromised condition (such as AIDS, lymphoma, long term corticosteroid treatment)
Patients presented with nausea, vomiting and fever.



 
 
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 
Difference in the overall symptoms relief between the intervention group and the placebo group as assessed by IBS-SSS  Time Frame 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Differences in stool consistency and frequency/ day between the intervention group and the placebo group over the study period. Differences in hematological parameters and lipid profile biomarkers between the intervention group and the placebo group over the study period.
 		 Time Frame 8 weeks 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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   N/A 
Date of First Enrollment (India)   29/07/2020 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder involving abdominal pain or discomfort and alterations in bowel habit (frequency, form, and passage).1,2 The prevalence of IBS in the United States varies widely because of the use of different diagnostic criteria and survey methods. The 2 most recent surveys reported a total prevalence of 7% to 14%, with a higher prevalence in women.3,4 Although IBS is not life threatening, the symptoms of IBS can have a profound impact on the patient’s emotional health and quality of life.

Abode Biotec India Private Limited has developed the probiotic strain (Bacillus coagulans) called ProBCPlus which is a well-studied strain of lactic acid-producing bacteria that can sustain the low pH of stomach acid and become active in the intestine.21,22.  

 

The current study is designed and will be conducted to evaluate the effect of 8 weeks supplementation of ProBCPlus in IBS-D subjects (defined by Rome III criteria) on IBS-D prominent symptoms (abdominal pain and other GI- related symptoms, stool consistency and frequency) and lipid profile.


 
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