drugset / Trial / NCT06750445

Fluoxetine for Refractory Constipation

NCT06750445

Completed 316 enrolled Zhifeng Zhao, PhD
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The goal of this clinical trial is to learn if fluoxetine works to treat refractory constipation . It will also learn about the safety of fluoxetine. The main questions it aims to answer are: Does fluoxetine increase the number of completely spontaneous bowel movements (CSBMs) per week? What medical problems do participants have when taking fluoxetine? Does fluoxetine improve psychological symptoms such as anxiety and depression in participants with refractory constipation? Researchers will compare fluoxetine to polyethylene glycol (PEG, a commonly used laxative) to see if fluoxetine works to treat refractory constipation. Participants will: Take fluoxetine (40 mg/day) or polyethylene glycol (once daily) for 6 months. Visit the clinic at baseline, and at 1 month, 3 months, and 6 months for checkups and tests. Record their bowel movements and any changes in symptoms, including anxiety, depression, and side effects.

Timeline

Start
2020-01-01
Primary completion
2024-06-30
Completion
2025-05-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Fluoxetine Small molecule 40 mg Oral
Comparator polyethylene glycol Other / unclassified 10 g

Indications