Probiotics and functional constipatio

Phase 3

• Registration Number: CTRI/2018/11/016399
• Lead Sponsor: nique Biotech Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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.

4.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)Timepoint: Visit 1- Treatment initiation ( Day 1) <br/ ><br>Visit 2- (Day 8 ± 2) <br/ ><br>Visit 3- (Day 15 ± 2) <br/ ><br>Visit 4- (Day 29 ± 2)

Secondary Outcome Measures

Name	Time	Method
Changes from baseline at EOS in: <br/ ><br>a.Stool frequency <br/ ><br>b.Stool consistency (as assessed by Bristol stool form scale). <br/ ><br>c.Difficulty degree of defecation-sensation of incomplete evacuation (Constipation Scoring System [CSS] scale). <br/ ><br>d.Defecation pain (Constipation Scoring System [CSS] scale). <br/ ><br>e.Abdominal Pain (Constipation Scoring System [CSS] scale). <br/ ><br>Timepoint: Visit 1- Treatment initiation ( Day 1) <br/ ><br>Visit 2- (Day 8 ± 2) <br/ ><br>Visit 3- (Day 15 ± 2) <br/ ><br>Visit 4- (Day 29 ± 2)