NCT06750445

Fluoxetine for Refractory Constipation

The Safety and Efficacy of Fluoxetine for Treatment of Refractory Constipation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 316 (actual)
• Sponsor: Zhifeng Zhao, PhD · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Refractory Constipation

Interventions

Type	Name	Description
DRUG	Fluoxetine	Patients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. Treatment was discontinued if serious adverse reactions developed or if no improvement was observed after dose escalation. Compliance and treatment progress were monitored via telephone follow-ups. For patients unable to have a bowel movement for three consecutive days or experiencing intolerable symptoms, polyethylene glycol (PEG, 10 g) was provided as rescue medication. Bowel movements within 24 hours of rescue medication use were excluded from the count of complete spontaneous bowel movements (CSBM).
DRUG	Polyethylene Glycol 400 0.4%	The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures.

Timeline

• Start date: 2020-01-01
• Primary completion: 2024-06-30
• Completion: 2025-05-30
• First posted: 2024-12-27
• Last updated: 2025-06-18

Locations

3 sites across 1 country: China