The Effects of Prucalopride in Patients With Constipation Predominant Irritable Bowel Syndrome

• Status: Recruiting
• Trial end date: 2021-11-20
• Target enrollment: 0
• Participant gender: All

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 treatment have been trying but no single drug is effective for every patients. After the discovery of 5HT4(5 hydroxytryptamine-4) receptor and its effect on gastrointestinal motility, 5HT4 receptor agonist becoming a good therapeutic tool in different functional gastrointestinal disorder. Prucalopride is a selective 5HT4 agonist and it has proven benefit in chronic idiopathic constipation but there is not enough evidence that it is effective in constipation predominant IBS.

Objective: To assess the efficacy of Prucalopride in constipation predominant IBS patients.

Material & method: 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. Their clinical history, examination & initial investigations report will be noted on the standard data sheet. Any alternative diagnosis if proven by clinical examination or laboratory investigation will be excluded from the study. Randomization into two groups (Prucalopride and placebo) will be performed by lottery. Patients will be randomly assigned to receive either Prucalopride 2 mg or placebo for 6 weeks. IBS symptoms will be assessed by IBS-SSS (symptom severity score) and IBS-QOL(quality of life) at the baseline, 2nd week and 6th week of treatment (end of treatment). Any adverse effect due to drugs will also be monitored by base line ECG, calculation of corrected QT interval and ECG monitoring (2 weeks and 6 weeks) during the course of treatment.

Data analysis By SPSS. IBS-SSS and IBS-QOL instrument scores will be expressed as mean ± standard deviation. Statistical analysis will be done by paired and unpaired 't' test. P value <0.05 will be considered statistically significant.

Ethical Consideration:

Every ethical issue will be discussed with the patient regarding the study and informed written consent will be obtained. There will be no chance of disclosure of information that will have been harmful to the patients or others. Permission have been taken from the concerned departmental ethical committee as well as ethical review committee of BSMMU in order to carry out the study.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
• Treatments: Prucalopride

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.