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Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

NCT06221722 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 150

Last updated 2025-07-24

No results posted yet for this 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.

Conditions

  • Constipation - Functional
  • Refractory Constipation
  • Fluoxetine
  • fMRI
  • Brain Connectivity
  • Treatment Efficacy
  • Somatic Symptom
  • Mental Symptom

Interventions

DIAGNOSTIC_TEST

BOLD-fMRI

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

DRUG

Regular treatment of functional constipation

at least 3 months of continuous regular treatment. This treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.

DRUG

fluoxetine

Fluoxetine oral treatment for 4 weeks.

Sponsors & Collaborators

  • Xijing Hospital of Digestive Diseases

    lead OTHER

Principal Investigators

  • Qingchuan Zhao, Prof. · Xijing Hospital of Digestive Diseases

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-11-01
Primary Completion
2025-09-01
Completion
2026-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06221722 on ClinicalTrials.gov