Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Last updated: January 28, 2024
Sponsor: Xijing Hospital of Digestive Diseases
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Somatoform And Dissociative Disorders

Treatment

fluoxetine

Regular treatment of functional constipation

BOLD-fMRI

Clinical Study ID

NCT06221722
KY20232332-C-1
  • Ages 18-45
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The goal of this observational study is to identify the characteristics of brain functional connectivity in refractory constipation and fluoxetine-sensitive patients. The main questions it aims to answer are:

  • Investigating the alterations in brain functional connectivity in patients with refractory constipation and fluoxetine-sensitive patients

  • Assessing the predictive value of brain functional connectivity regarding the efficacy of fluoxetine and standard protocol treatments for constipation.

Participants will receive:

  • Standard physiological and psychological assessments of constipation

  • BOLD-fMRI tests

  • Standard protocol and fluoxetine treatment

If there is a comparison group: Researchers will compare:

Refractory group/Fluoxetine sensitive group to see the specific brain alterations.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18≤ age ≤ 45 years old
  • Right-handed
  • Patients diagnosed as functional constipation according to the Rome IV criteria
  • Informed consent of patients

Exclusion

Exclusion Criteria:

  • Complicated with gastrointestinal organic disease or significant functionalabnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon,pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
  • Long-term intense exercise (continuous exercise for more than 8 hours per week, suchas marathon runners or triathletes)
  • No history of chronic pain, no recent major trauma
  • Drug abuse or tobacco dependence (half a pack or more per day)
  • Combined hypothyroidism and Parkinson's disease
  • Patients with confirmed mental illness or neurological disorders who take psychotropicdrugs, analgesics or hormones
  • History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
  • Contraindications to functional magnetic resonance imaging (claustrophobia, metalimplants)
  • Pregnant or lactating women with constipation after delivery
  • Patients with other benign and malignant tumors and autoimmune diseases
  • Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.
  • Heart disease, organ failure and other chronic diseases that require long-termmedication or affect the quality of life

Study Design

Total Participants: 150
Treatment Group(s): 3
Primary Treatment: fluoxetine
Phase:
Study Start date:
November 01, 2023
Estimated Completion Date:
September 01, 2026

Connect with a study center

  • People's Hospital of Ningxia Hui Autonomous Region

    Yinchuan, Ningxia 750002
    China

    Active - Recruiting

  • Xi'an International Medical Center Hospital

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

  • Xijing Hospital, Fourth Military Medical University

    Xi'an, Shaanxi 710032
    China

    Active - Recruiting

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