| CTRI Number |
CTRI/2024/04/066125 [Registered on: 23/04/2024] Trial Registered Prospectively |
| Last Modified On: |
18/12/2024 |
| 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 clinical study to evaluate and compare the safety and efficacy of a test product (Probiotic Capsule) and placebo product in healthy adult subjects. |
|
Scientific Title of Study
|
A Double-Blind, Randomized, Two-Arm, Placebo-Controlled, Comparative Clinical Study to Evaluate the Safety and Efficacy of Bacillus coagulans BCP92 in Healthy Adult Subjects. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| C3B04178; Version: 01, Dated 22 Mar 24 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vipul Doshi |
| Designation |
Principal Investigator |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17,
Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
07966135601 |
| Fax |
|
| Email |
vipul4500@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Simran Sethi |
| Designation |
Director Consumer Research |
| Affiliation |
Cliantha Research |
| Address |
Consumer Research Department,
Corporate House 17, Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT
380054
India |
| Phone |
9825784942 |
| Fax |
|
| Email |
ssethi@cliantha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sohel Shaikh |
| Designation |
Manager – Scientific and Regulatory affairs |
| Affiliation |
Pellucid Lifesciences Pvt. Ltd. |
| Address |
Plot No.: 3538, Phase - 4,
GIDC Industrial Estate,
Chhatral – 382729,
Dist - Gandhinagar, Gujarat, India.
Gandhinagar
GUJARAT
382729
India |
| Phone |
9822979295 |
| Fax |
|
| Email |
sohel@pellucidlifesciences.com |
|
|
Source of Monetary or Material Support
|
| Cliantha Research, Corporate House 17, Sigma 1 Corporate House, BH. Rajpath Club, Off Sindhubhavan Road, Nr. Mann Party Plot Cross Road, Bodakdev, Ahmedabad-380054, Gujarat, India. |
| Pellucid Lifesciences Pvt. Ltd., Plot No.: 3538, Phase - 4, GIDC Industrial Estate, Chhatral – 382729, Dist - Gandhinagar, Gujarat, India. |
|
|
Primary Sponsor
|
| Name |
Pellucid Lifesciences Pvt. Ltd. |
| Address |
Plot No.: 3538, Phase - 4,
GIDC Industrial Estate,
Chhatral - 382729
Dist - Gandhinagar, Gujarat, India. |
| Type of Sponsor |
Other [Probiotics Manufacturing Biotechnology company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Not Applicable |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vipul Doshi |
Cliantha Research |
Corporate House 17,
Sigma 1 Corporate House,
BH. Rajpath Club, Off Sindhubhavan Road,
Nr. Mann Party Plot Cross Road,
Bodakdev, Ahmedabad-380054, Gujarat.
Ahmadabad
GUJARAT |
07966135601
vipul4500@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| ACEAS - Independent Ethic Committee |
Approved |
| ACEAS - Independent Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Adult subjects of both sex with age between 18 and 55 years having good general health as determined by the Investigator on the basis of medical history, physical examination and vital signs |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placebo |
One capsule will be consumed with water daily (before 1 hour of consuming meal) for a duration of 42 days. |
| Intervention |
Probiotic Capsule containing Bacillus coagulans BCP92 |
One capsule will be consumed with water daily (before 1 hour of consuming meal) for a duration of 42 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Subjects having good general health as determined by the Investigator on the basis of medical history, physical examination and vital signs.
2) Females of Childbearing potential must have a negative urine pregnancy test performed during screening.
3) Subjects who agree to refrain from using any probiotic food or supplement, including yogurt/buttermilk during the course of this study.
4) Subjects who agree to refrain from consuming pharmaceuticals such as anti-inflammatory, immunosuppressive, and laxative agents.
5) Subjects willing to maintain a consistent diet and lifestyle routine throughout the study.
6) Subject willing to provide blood and stool samples during the study duration.
|
|
| ExclusionCriteria |
| Details |
1) Subjects having history of acute peptic ulcer, severe GERD and/or ulcer complications or other functional GI disorder.
2) Subjects with any pathological problem associated with gastroesophageal reflux disease including Barretts esophagus and malignancy.
3) Subjects with any clinically significant medical history, medical finding or an ongoing medical or psychiatric condition which in the opinion of the Investigator could jeopardize the safety of the subject or impact the validity of the study results or interfere with the completion of study according to the protocol.
4) Subjects who are regularly using any medications affecting bowel habits, such as irritable bowel syndrome, functional bloating, and functional diarrhea.
5) Subjects consuming probiotics or prebiotics 30 days prior to study.
6) Subjects with known allergy or hypersensitivity to probiotics and/or any ingredients of the test product. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in gut microbiome by metagenomic analysis.
2. Change in Quality of life using Digestive Associated Quality of Life Questionnaire (DQLQ). |
1. Day 00 (before product administration), Day 42
2. Day 00 (before product administration), Day 21, Day 42
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in eating behavior using Three-Factor Eating Questionnaire-R18 (TFEQ-R18) |
Day 00 (before product administration), Day 21, Day 42 |
| Change in Daily energy levels using Visual Analogue Scale (VAS) |
Day 00 (before product administration), Day 21, Day 42 |
| Change in Liver Function tests, Renal Function Tests, Random Blood glucose, Thyroid Function Test, CBC and Urine Test. |
Day 00 (before product administration), Day 42 |
Exploratory Endpoints:
Change in Short-Chain Fatty Acids (SCFAs) using Gas Chromatography Mass Spectrometry |
Day 00 (before product administration), Day 42 |
Safety Endpoints:
Change in Vital Signs and incidence of undesirable /adverse event.
|
Day 00 (before product administration), Day 21, Day 42 |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/05/2024 |
| Date of Study Completion (India) |
22/06/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="1"
Days="12" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 blinded, randomized, two-arm,
placebo controlled, comparative clinical study to evaluate the safety and
efficacy of probiotic product in healthy adult subjects.
The potential subjects will be screened as per
the inclusion and exclusion criteria only after obtaining written informed
consent from the subjects.
All eligible subjects will undergo laboratory
evaluation (blood, urine and stool tests) and evaluation using different
scales/questionnaires. Safety will be assessed throughout the study by
monitoring vital signs and adverse events. |