| CTRI Number |
CTRI/2017/11/010539 [Registered on: 17/11/2017] Trial Registered Prospectively |
| Last Modified On: |
28/05/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Probiotic |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Effect of probiotic Bacillus coagulans Unique IS2 in Adults with Constipation |
|
Scientific Title of Study
|
A Multi-Center, Double Blind, Randomized, Parallel-Group, Placebo-controlled Study to Evaluate the Safety and Efficacy of Bacillus Coagulans Unique IS2 capsules in the Treatment of Functional Constipation in Adults. |
| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BC-UIS2/PMS/2017/09 Version 1.0, 08 Sep 2017 |
NIL |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
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| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Mr Pawan Bhusari |
| Designation |
CEO |
| Affiliation |
|
| Address |
1st Floor, Clinical Research Department
Abiogenesis Clinpharm Private Limited
8-2-596A and B/1 Road No 10 Banjara Hills
Hyderabad
Hyderabad
ANDHRA PRADESH
500034
India |
| Phone |
04038117077 |
| Fax |
|
| Email |
pawanbhusari@abiogenesisclinpharm.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr N Jayanthi |
| Designation |
Manager Business Development |
| Affiliation |
|
| Address |
Administration Block
1st Floor
Plot No 2 Phase II
Alexandria Knowledge Park
Kolthur Village
Shameerpet Mandal Ranga Reddy Dist Hyderabad
Rangareddi
ANDHRA PRADESH
500078
India |
| Phone |
04023751346 |
| Fax |
|
| Email |
jayanthi@uniquebiotech.com |
|
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Source of Monetary or Material Support
|
| Unique Biotech Limited
Plot No 2 Phase II
Alexandria Knowledge Park
Kolthur Village
Shameerpet Mandal Ranga Reddy Dist Hyderabad-500 078
Andhra Pradesh |
|
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Primary Sponsor
|
| Name |
Unique Biotech Ltd |
| Address |
Plot No 2, Phase -11, Alexandria Knowledge Park Kolthur Village, Shameerpet Mandal Ranga Reddy District Hyderabad -500078, india |
| Type of Sponsor |
Pharmaceutical industry-Indian |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Vineet Kumar Shukla |
KRM Hospital & Research Centre |
General Medicine Department, Research Room No 1
3/92-93,Vijayant khand
Gomti Nagar
Lucknow
UTTAR PRADESH |
917007208089
krmhrclko@gmail.com |
| Dr Sandeep Kumar Gupta |
MV Hospital & Research Centre |
General Medicine Department, Room No 1 1st floor
314/30,Mirzamandi Chowk,
Lucknow
UTTAR PRADESH |
05222258215
mvhrclko@gmail.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for MV Hospital and Research Centre |
Approved |
| KRM Hospital Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K590||Constipation, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Bacillus Coagulans Unique IS2 capsules |
Taken orally, one capsule daily for 28 days |
| Comparator Agent |
Placebo capsules |
Taken orally, one capsule daily for 28 days |
|
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Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Male or female subject aged between 18 and 65 years old (both inclusive).
2. Has diagnosis of functional constipation according to Rome Criteria III.
3. Willing to give IEC approved informed consent.
4. Willing to abide by the study requirements.
|
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| ExclusionCriteria |
| Details |
1. Subjects who have undergone major abdominal surgery.
2. Subjects with a documented history of slow colonic transit.
3. Presence of any concomitant diseases such as organic GI diseases and/or lactose and gluten intolerance; medical or psychiatric illness
4. Subjects with clinical features suggestive of alarming symptoms (rectal bleeding, weight loss, etc.)
5. Family history of peptic ulcer, colorectal cancer, or IBD
6. Abnormal laboratory data or thyroid function.
7. Participated in any clinical trial in the past 90 days.
8. Have received any probiotic formulation in the past 30 days.
9. Known or expected hypersensitivity to any of the active substances or excipients.
10. Subject is pregnant or lactating.
11. Subject allergic or atopic to any of the ingredients of the study medication
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Method of Generating Random Sequence
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Permuted block randomization, fixed |
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Method of Concealment
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Pre-numbered or coded identical Containers |
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Blinding/Masking
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Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Treatment success (defined as 3 or more spontaneous stools per week) |
Baseline (Day 0) and Day 29 (End of treatment) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
Changes from baseline at EOS in:
a. Stool frequency
b. Stool consistency (as assessed by Bristol stool form scale).
c. Difficulty degree of defecation-sensation of incomplete evacuation (Constipation Scoring System [CSS] scale).
d. Defecation pain (Constipation Scoring System [CSS] scale).
e. Abdominal Pain (Constipation Scoring System [CSS] scale).
|
Baseline (Day 0) and Day 29 (End of treatment) |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
18/12/2017 |
| Date of Study Completion (India) |
10/06/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
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Publication Details
|
None yet |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This is a prospective, double-blind, multi-centric, randomized, parallel-group study to evaluate the safety and efficacy of Bacillus Coagulans IS2 capsules in the treatment of functional constipation in adults. In all, 100 subjects will be randomized by block randomization technique in order to enroll subjects in a targeted ratio of 1:1 (test: placebo). Test group and placebo group will have approximately equal number of subjects in different age groups of adults. Subjects who have diagnosis of functional constipation according to Rome III criteria in whom, slow colonic transit has been ruled out will be randomized to receive either test or placebo capsules. The IP will be administered for a period of 28 days orally one capsule per day. Subjects will be evaluated for the treatment success (defined as 3 or more spontaneous stools per week), stool frequency and consistency (according to Bristol Stool Form Scale), difficulty of defecation, defecation pain and abdominal pain by (Constipation Scoring System [CSS]†scale. |