Fluoxetine for Refractory Constipation

NCT06750445 | Completed

• 1 other identifier: XJLL-KY20222069
• Study Type: interventional
• Target: 316
• Locations: 1 country
• Sites: 3

Brief 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

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with a CSBM of 3 or more per week

  The primary endpoint of this study is the proportion of patients achieving a weekly frequency of three or more complete spontaneous bowel movements (CSBMs) after six months of treatment. A CSBM is defined as a bowel movement that occurs without the use of rescue medication (e.g., polyethylene glycol) within the preceding 24 hours. This endpoint aims to evaluate the efficacy of fluoxetine in improving bowel function in patients with refractory constipation as compared to the control group.

  baseline, six months after treatment

Secondary Outcomes (3)

• Mean number of spontaneous bowel movements (SBMs) per week

  baseline, 1 month, 3 months, 6 months

• Mean number of complete spontaneous bowel movements (CSBMs) per week

  baseline, 1 month, 3 months, 6 months

• Stool consistency (Bristol Stool Form Scale, BSFS, scores of 3-5)

  baseline, 1 month, 3 months, 6 months

Study Arms (2)

Fluoxetine Treatment Group

EXPERIMENTAL

Patients in the fluoxetine group received oral fluoxetine starting at 40 mg/day for six months. The dose could be increased to 60 mg/day if symptoms persisted or reduced if mild adverse effects (e.g., dizziness, nausea, tremors) occurred. 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: Fluoxetine

PEG Treatment Group

ACTIVE COMPARATOR

The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures.

Drug: Polyethylene Glycol 400 0.4%

Interventions

Fluoxetine DRUG

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).

Also known as: polyethylene glycol

Fluoxetine Treatment Group

Polyethylene Glycol 400 0.4% DRUG

The control group (PEG) used polyethylene glycol as a rescue medication under the same conditions, following similar monitoring and follow-up procedures.

PEG Treatment Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• individuals aged 18 to 70 years;
• patients meeting the Rome IV diagnostic criteria for chronic constipation, defined by at least two symptoms: straining, lumpy or hard stools (Bristol Stool Scale types 1-2), incomplete evacuation, anorectal obstruction, need for manual maneuvers, or spontaneous bowel movements occurring less than three times per week. These symptoms must have persisted for a minimum of six months, with the diagnostic criteria being met for at least the past three months;
• refractory constipation, defined as the use of at least three medications (including osmotic agents, laxatives, prokinetics, biofeedback and probiotics, surgery) for more than three months, with unsatisfactory treatment outcomes;
• patients present indications for fluoxetine, such as comorbid depression;
• patients who voluntarily provided informed consent prior to enrollment.

You may not qualify if:

• women who are pregnant or lactating;
• presence of cardiovascular conditions, organ dysfunction, immune disorders, or infections;
• concurrent gastrointestinal organic conditions such as tuberculosis, polyps, Crohn's disease, tumors, etc.;
• prior abdominal surgeries;
• use of psychotropic medications; 6) diagnosis of hypothyroidism or Parkinson's disease.

Sponsors & Collaborators

• Zhifeng Zhao, PhD: lead

Study Sites (3)

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750011, China

Location

The First Affiliated Hospital of the Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

Location

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Constipation

Interventions

Fluoxetine; Polyethylene Glycols

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; Ethylene Glycols; Glycols; Alcohols; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 17, 2024
• First Posted: December 27, 2024
• Study Start: January 1, 2020
• Primary Completion: June 30, 2024
• Study Completion: May 30, 2025
• Last Updated: June 18, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)