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Completed

NCT Number: NCT06750445

Fluoxetine for Refractory Constipation

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.

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Key information

Conditions

Refractory Constipation Constipation Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: polyethylene glycol

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.

Primary outcomes

  1. Proportion of patients with a CSBM of 3 or more per week

    Time frame: baseline, six months after treatment

    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.

Secondary outcomes

  1. Mean number of spontaneous bowel movements (SBMs) per week

    Time frame: baseline, 1 month, 3 months, 6 months

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

    Time frame: baseline, 1 month, 3 months, 6 months

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

    Time frame: baseline, 1 month, 3 months, 6 months

Sponsors and collaborators

Lead sponsor

Zhifeng Zhao, PhD

Other

Registry information

Official study title

The Safety and Efficacy of Fluoxetine for Treatment of Refractory Constipation

Important dates

Study start
2020
Primary completion
2024
Study completion
2025
First posted
Dec 27, 2024
Registry last updated
Jun 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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