Effect of probiotic Bacillus coagulans Unique IS2 in Adults with Constipation

Phase 3

Completed

• Conditions: Constipation,

• Registration Number: CTRI/2017/11/010539
• Lead Sponsor: Unique Biotech Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-18
• Study Completion: 2018-10-06
• Last Update Posted: 2019-05-28

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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.
• Willing to abide by the study requirements.

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment success (defined as 3 or more spontaneous stools per week)	Baseline (Day 0) and Day 29 (End of treatment)

Secondary Outcome Measures

Name	Time	Method
Changes from baseline at EOS in:	a.Stool frequency

Trial Locations

Locations (2)

KRM Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

MV Hospital & Research Centre; 🇮🇳 Lucknow, UTTAR PRADESH, India

KRM Hospital & Research Centre

🇮🇳Lucknow, UTTAR PRADESH, India

Dr Vineet Kumar Shukla

Principal investigator

917007208089

krmhrclko@gmail.com