Status:
UNKNOWN
The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Conditions:
Irritable Bowel Syndrome
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
PHASE3
Brief Summary
Irritable bowel syndrome (IBS) is very common functional gastrointestinal disorder in daily gastrointestinal practice. Its etiology is multifactorial and incompletely understood. Different types of tr...
Detailed Description
Consecutive patients of both sexes, age more than 18 years attended the outpatient department of Gastroenterology meeting the inclusion Criteria of IBS-C will be initially enrolled for the study. Thei...
Eligibility Criteria
Inclusion
- Age:18-65 years.
- Patients who will Meet Rome IV criteria for IBS-Constipation (IBS-C).
- Patients classified as IBS-C had \> 25% hard or lumpy stool (Bristol stool scale 1-2) and \< 25% loose or watery (Bristol stool scale 6-7).
- Absence of alarm features (rectal bleeding, anemia, unexplained weight loss, and a family history of organic GI diseases (e.g. colon cancer or inflammatory bowel disease).
- Patients more than 55 years when full colonoscopy will normal.
- Patients given informed written consent.
Exclusion
- Current treatment with laxative and Selective Serotonin Re-uptake Inhibitor.
- Unable or Unwilling to stop medication including lactulose, lubiprostone etc.
- Known organic bowel diseases (e.g. inflammatory bowel disease, tuberculosis, diverticular disease, etc.).
- Secondary causes of constipation e.g. Diabetes Mellitus, Hypothyroidism, Cerebrovascular disease and Parkinsonism. Known severe depression and psychiatric disorder.
- Clinical feature suggestive of organic disease (H/O weight loss, per rectal bleeding, family history of malignancy etc).
- Previous GI surgery.
- Pregnancy or lactation.
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 20 2021
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04757493
Start Date
March 10 2021
End Date
November 20 2021
Last Update
October 22 2021
Active Locations (1)
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1
Shahbag
Dhaka, Bangladesh, 1000