Trials / Recruiting

RecruitingNCT06221722

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study

Status: Recruiting
Phase: —
Study type: Observational
Enrollment: 150 (estimated)

Sponsor: Xijing Hospital of Digestive Diseases · Academic / Other
Sex: All
Age: 18 Years – 45 Years
Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

Start date: 2023-11-01
Primary completion: 2025-09-01
Completion: 2026-09-01
First posted: 2024-01-24
Last updated: 2025-07-24

Locations

3 sites across 1 country: China

Source: ClinicalTrials.gov record NCT06221722. Inclusion in this directory is not an endorsement.