Status:

RECRUITING

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Lead Sponsor:

Xijing Hospital of Digestive Diseases

Conditions:

Constipation - Functional

Refractory Constipation

Eligibility:

All Genders

18-45 years

Brief 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 ans...

Eligibility Criteria

Inclusion

  • 18≤ age ≤ 45 years old
  • Right-handed
  • Patients diagnosed as functional constipation according to the Rome IV criteria
  • Informed consent of patients

Exclusion

  • Complicated with gastrointestinal organic disease or significant functional abnormalities (tuberculosis, polyps, Crohn's disease, tumors, congenital megacolon, pelvic floor muscle relaxation, abnormal colonic transit test, etc.)
  • Long-term intense exercise (continuous exercise for more than 8 hours per week, such as marathon runners or triathletes)
  • No history of chronic pain, no recent major trauma
  • Drug abuse or tobacco dependence (half a pack or more per day)
  • Combined hypothyroidism and Parkinson's disease
  • Patients with confirmed mental illness or neurological disorders who take psychotropic drugs, analgesics or hormones
  • History of abdominal surgery (appendectomy, hysterectomy, or cholecystectomy)
  • Contraindications to functional magnetic resonance imaging (claustrophobia, metal implants)
  • Pregnant or lactating women with constipation after delivery
  • Patients with other benign and malignant tumors and autoimmune diseases
  • Infectious diseases such as hepatitis B, hepatitis C, AIDS, etc.
  • Heart disease, organ failure and other chronic diseases that require long-term medication or affect the quality of life

Key Trial Info

Start Date :

November 1 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

September 1 2026

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT06221722

Start Date

November 1 2023

End Date

September 1 2026

Last Update

July 24 2025

Active Locations (3)

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Page 1 of 1 (3 locations)

1

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, China, 750002

2

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, China, 710032

3

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China, 710032