Actively Recruiting

Age: 18Years - 45Years
All Genders
Healthy Volunteers
NCT06221722

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Led by Xijing Hospital of Digestive Diseases · Updated on 2025-07-24

150

Participants Needed

3

Research Sites

147 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Who Can Participate

Age: 18Years - 45Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

You will not qualify if you...

  • Presence of gastrointestinal organic diseases or significant functional abnormalities (e.g., tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test)
  • Engages in long-term intense exercise exceeding 8 hours per week
  • No history of chronic pain or recent major trauma
  • Drug abuse or tobacco dependence (half a pack or more per day)
  • Has hypothyroidism or Parkinson's disease
  • Confirmed mental illness or neurological disorders taking psychotropic drugs, analgesics, or hormones
  • History of abdominal surgery such as appendectomy, hysterectomy, or cholecystectomy
  • Contraindications to functional MRI (such as claustrophobia or metal implants)
  • Pregnant or lactating women or constipation after delivery
  • Patients with benign or malignant tumors and autoimmune diseases
  • Infectious diseases including 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

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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

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Research Team

Z

Zhifeng Zhao

CONTACT

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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Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation | DecenTrialz