CTRI/2018/11/016399
Not yet recruiting
Phase 3
To evaluate the role of Probiotics in the treatment of Functional constipationin adults.
nique Biotech Limited0 sites0 target enrollmentTBD
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- nique Biotech Limited
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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