| CTRI Number |
CTRI/2023/01/048644 [Registered on: 02/01/2023] Trial Registered Prospectively |
| Last Modified On: |
30/12/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
A study to assess the effects of 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:2.0, Dated 07 July 2022 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ambrish C |
| Designation |
Principal Investigator |
| Affiliation |
Medstar Speciality Hospital |
| Address |
Medstar Speciality Hospital #641/17/1/3, kodigehalli main road, Sahakarnagar Bangalore-560092, Karnataka, India
Bangalore
KARNATAKA
560092
India |
| Phone |
08041127524 |
| Fax |
|
| Email |
medstarclinicalresearch@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094 India
Bangalore
KARNATAKA
560094
India |
| Phone |
9538961761 |
| Fax |
|
| Email |
divya@bioagiletherapeutics.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya C |
| Designation |
CEO |
| Affiliation |
Bioagile Therapeutics Pvt. Ltd |
| Address |
#2/5, Dahlia Building, 3rd Floor, 80 Feet Road, RMV 2nd Stage,, Bengaluru, Karnataka 560094 India
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 |
Plot no: 34 A, Huda heights, 2nd floor, Road no:12
Banjara hills, near lotus pond, Telangana 500033. INDIA
|
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ambrish C |
MedStar Speciality Hospital |
OPD Room No-1, Ground Floor #641/17/1/3, Kodigehalli Main Road,Sahakarnagar, Bangalore- 560092, Karnataka, India
Bangalore
KARNATAKA |
80-41127524
medstarclinicalresearch@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MedStar Speciality Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K580||Irritable bowel syndrome with 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.
|
|
| 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.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. |
|
|
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 |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Difference in hematological parameters and lipid profile biomarkers in-between 2 groups over the study period.
2.Differences in stool consistency and frequency per day in-between 2 groups over the study period |
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
03/01/2023 |
| 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="2"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
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. Irritable bowel. |