Actively Recruiting
Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-24
150
Participants Needed
3
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying brain functional connectivity in patients with refractory constipation and those who respond to fluoxetine treatment. The study aims to understand how brain connectivity changes in these patients and to predict how well they might respond to fluoxetine or standard treatments. This observational study focuses on adults aged 18 to 45 diagnosed with functional constipation based on the Rome IV criteria. Participants will undergo standard physiological and psychological assessments related to constipation. They will have BOLD-fMRI scans to evaluate brain function. Patients with refractory constipation have already undergone at least 3 months of regular treatment involving laxatives and a high-fiber diet. Following this, they receive a 4-week course of fluoxetine. Groups include those sensitive and insensitive to fluoxetine, non-refractory constipation patients, and healthy volunteers without constipation symptoms. During the study, participants will be assessed before and after fluoxetine treatment with brain scans and self-assessment questionnaires measuring quality of life, somatic symptoms, anxiety, depression, and constipation severity. The main measurement is the change in brain functional connectivity observed through BOLD-fMRI before and after treatment. The study also looks at changes in various self-reported symptom scores to better understand treatment effects. Participation lasts through the treatment and evaluation periods with ongoing monitoring of symptoms and brain function.
CONDITIONS
Brief Title
Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 45 years old
- Right-handed
- Diagnosed with functional constipation according to Rome IV criteria
- Provided informed consent to participate
You will not qualify if you...
- Presence of gastrointestinal organic diseases or significant functional abnormalities such as tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, or abnormal colonic transit test
- Engaged in long-term intense exercise exceeding 8 hours per week
- History of chronic pain or recent major trauma
- Drug abuse or tobacco dependence of half a pack or more per day
- Combined hypothyroidism or Parkinson's disease
- Mental illness or neurological disorders treated with psychotropic drugs, analgesics, or hormones
- History of abdominal surgery including appendectomy, hysterectomy, or cholecystectomy
- Contraindications to MRI such as claustrophobia or metal implants
- Pregnant or lactating women with constipation after delivery
- Other benign or malignant tumors and autoimmune diseases
- Infectious diseases such as hepatitis B, hepatitis C, AIDS
- Heart disease, organ failure, or other chronic diseases requiring long-term medication or affecting quality of life
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 months
Participants who undergo routine treatment for functional constipation are observed during at least 3 months of continuous regular treatment including osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
Visit frequency depends on routine care
Duration - 4 weeks
Participants receive fluoxetine oral treatment for 4 weeks to evaluate therapeutic effects on refractory constipation.
1 baseline visit and 1 follow-up visit
Duration - 5 weeks total (1 week before and 4 weeks after fluoxetine treatment)
Participants undergo BOLD-fMRI scans to evaluate brain functional connectivity before and after fluoxetine treatment.
2 visits (in-person) for imaging
Trial Site Locations
Total: 3 locations
1
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China, 750002
Actively Recruiting
2
Xi'an International Medical Center Hospital
Xi'an, Shaanxi, China, 710032
Actively Recruiting
3
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Actively Recruiting
Research Team
Z
Zhifeng Zhao
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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