| CTRI Number |
CTRI/2018/10/015913 [Registered on: 05/10/2018] Trial Registered Prospectively |
| Last Modified On: |
10/10/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Nutraceutical |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
In this study the effectiveness of probiotic on the microflora of the stomach and its recovery in the stools will be studied in healthy individuals in comparison to an inactive. |
|
Scientific Title of Study
|
The effect of Bacillus coagulans MTCC 5856(LactoSpore®) on the modulation of gut microflora and its fecal recovery in healthy human subjects: A randomized double blind placebo controlled clinical trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CPL/65/LS/May/18V1.019-MAY-18 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Hema Divakar |
| Designation |
Gynecologist, Obstetrician |
| Affiliation |
Divakars Speciality Hospital |
| Address |
Gynecology and Obstetrics Clinic, Room no. 220, 9th Cross Road, 2nd Phase, J P Nagar, Next to Nilgiris.
Bangalore
KARNATAKA
560078
India |
| Phone |
9900154448 |
| Fax |
|
| Email |
divakarsspecialityhospital@gmail.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Renuka Jain |
| Designation |
Vice President New Products |
| Affiliation |
Sami labs Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
renuka@samilabs.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Shaji Paulose |
| Designation |
General Manager |
| Affiliation |
ClinWorld (P) Limited |
| Address |
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area.
Bangalore
KARNATAKA
560058
India |
| Phone |
08028397973 |
| Fax |
|
| Email |
shaji@clinworld.org |
|
|
Source of Monetary or Material Support
|
| Sami Labs Limited
19/1 & 19/2, I Main, II Phase, Peenya Industrial Area,
Bangalore, Karnataka. 560058. |
|
|
Primary Sponsor
|
| Name |
Sami Labs Limited |
| Address |
19/1 & 19/2,I Main, II Phase, Peenya Industrial Area, Bangalore, Karnataka. 560058. |
| Type of Sponsor |
Other [Manufactures and markets phytonutrients & standardized herbal extracts and nutritional supplements] |
|
|
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 Hema Divakar |
Divakars Speciality Hospital |
Gynecology & Obstetrics Clinic, Room no. 220, 9th Cross Road, 2nd Phase, J P Nagar, Next to Nilgiris.
Bangalore
KARNATAKA |
9900154448
divakarsspecialityhospital@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Hairline Research Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age between 25-55 years and BMI between 20-27 kg/m2 (both inclusive) |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Bacillus coagulans MTCC 5856 (LactoSpore®) |
One capsule containing 2 billion spores per day for 28 days |
| Comparator Agent |
Placebo |
One capsule containing Maltodextrin 200 mg per day for 28 days |
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1 BMI between 20-27 kg/m2 (both inclusive).
2 Non vegetarians and Non smokers
3 Willing to come for regular follow –up visits.
4 Able to give written informed consent.
5 Willing to avoid the prebiotic and probiotic food supplements, laxatives and foods having laxative effects during the study. |
|
| ExclusionCriteria |
| Details |
1 Use of antibiotics.
2 Any underlying gastrointestinal complaints like colonic irritation.
3 Not taking any medication with gastrointestinal activity like laxatives.
4 Had not taken antibiotics for 3 months prior to starting the study.
5 Consumption of Yogurt, curd, prebiotic or probiotic supplements as part of their daily diet.
6 Participation in a clinical study during the preceding 90 days.
7 Not willing to abide by the study procedures or not willing to provide stool samples for the study.
8 Pregnancy and lactating.
9 Presently suffering from any inflammatory disorders and mental illness.
10 History of drug or alcohol abuse in the last 6 months. |
|
|
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 |
1 Biomarkers
2 Faecal Sampling
3 Subject Abdominal Life Questionnaire
4 Bristol Stool Chart Questionnaire |
1 Biomarkers(Visit2 and Visit4)
2 Faecal Sampling(Visit2 and Visit4)
3 Subject Abdominal Life Questionnaire(Visit2,Visit3 and Visit4)
4 Bristol Stool Chart Questionnaire(Visit2 and Visit4) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1 Adverse and Serious adverse events |
1 Adverse and Serious adverse events (Visit3 and Visit4) |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
12/10/2018 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Will be published on trial completion. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This prospective, randomized, double blind, placebo controlled clinical trial is designed to study the efficacy of Bacillus coagulans MTCC 5856 on modulation of gut microflora and its faecal recovery in healthy human subjects. The trial will be conducted in adult male and female healthy volunteers between 25 to 55 years and having body mass index between 20 to 27 kg/m2 (both inclusive). The individual subject participation will be for 28 days. The study aims at measuring the gastrointestinal survival of Bacillus coagulans and assessing its impact on faecal microflora. The study outcomes will include change in biomarkers, faecal sampling (RT-PCR and 16S Illumina based sequencing), subject abdominal life questionnaire and Bristol stool chart questionnaire. Statistical analysis will be performed as listed in the protocol. |