Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

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

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.

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