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

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug, Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 18≤ age ≤ 45 years old

• Right-handed

• Patients diagnosed as functional constipation according to the Rome IV criteria

• Informed consent of patients

Locations
Other Locations
China
Xi'an International Medical Center Hospital
RECRUITING
Xi'an
Xijing Hospital, Fourth Military Medical University
RECRUITING
Xi'an
People's Hospital of Ningxia Hui Autonomous Region
RECRUITING
Yinchuan
Contact Information
Primary
Zhifeng Zhao
zhaozhifeng@outlook.com
13519171072
Time Frame
Start Date: 2023-11-01
Estimated Completion Date: 2026-09-01
Participants
Target number of participants: 150
Treatments
Refractory constipation: fluoxetine sensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.~After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.
Refractory constipation: fluoxetine insensitive
Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.~After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.
Non-refractory constipation
Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
Health Control
Volunteers without symptoms of constipation
Related Therapeutic Areas
Sponsors
Leads: Xijing Hospital of Digestive Diseases

This content was sourced from clinicaltrials.gov