Evaluating brain connectivity in patients with refractory constipation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to explore the characteristics of brain functional connectivity in patients suffering from refractory constipation and those who are sensitive to fluoxetine. It will assess how these brain connectivity patterns can predict the effectiveness of fluoxetine and standard treatments for constipation. Participants will undergo standard physiological and psychological assessments, as well as BOLD-fMRI tests to evaluate brain activity. The study will compare brain alterations between refractory constipation patients and fluoxetine-sensitive patients to identify potential biomarkers for treatment outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

* 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

Where it's running

• People's Hospital of Ningxia Hui Autonomous Region
  Yinchuan, Ningxia, China Recruiting
• Xi'an International Medical Center Hospital
  Xi'an, Shaanxi, China Recruiting
• Xijing Hospital, Fourth Military Medical University
  Xi'an, Shaanxi, China Recruiting

Study contacts

• Study coordinator: Zhifeng Zhao
• Email: zhaozhifeng@outlook.com
• Phone: 13519171072

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.