Skip to main content
Clinical Trials/CTRI/2018/11/016399
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Sponsor
nique Biotech Limited

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

Similar Trials