Overview

Study of Comparative Effectiveness of Prucalopride and Lubiprostone in Constipation Predominant Irritable Bowel Syndrome

Status:
Recruiting
Trial end date:
2022-03-01
Target enrollment:
0
Participant gender:
All
Summary
This will be a semi-experimental study on constipation predominant IBS patient. One group of patient will receive prucalopride 2mg daily and another group of patient will receive lubiprostone 8 microgram twice daily. IBS-SSS and IBS-QOL score will be recorded at baseline and at follow up at 3 week and 6 week. Effectiveness of both drug will be evaluated by comparing the baseline data with data at 3 week and 6 week(IBS-SSS and IBS-QOL).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
Treatments:
Prucalopride
Criteria
Inclusion criteria:

- Meet Rome IV criteria for IBS-C

- Patients given informed written consent

Exclusion Criteria:

- Current treatment with laxative or SSRI

- Use of any medication indicated for treatment of IBS within preceding 2 weeks of
enrollment

- Organic disorder of the large or small bowel (e.g. inflammatory bowel disease,
tuberculosis, diverticular disease)

- Diagnosis of any medical condition associated with constipation except IBS-C (e.g DM,
Hypothyroidism, CVD, parkinsonism)

- Clinical feature suggestive of organic disease (e.g. unexplained significant weight
loss, rectal bleeding)

- Previous gastrointestinal or abdominal surgery (except for common causes unrelated to
IBS)

- Abnormal laboratory tests (CBC, CRP, RBS, S. Creatinine, S.TSH, ECG)

- Mechanical obstruction

- Known severe depression, psychiatric disorder.

- Pregnancy or lactation