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
Xijing Hospital of Digestive Diseases
150 participants
Nov 1, 2023
OBSERVATIONAL
Conditions
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 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.
Eligibility
Inclusion Criteria4
- ≤ age ≤ 45 years old
- Right-handed
- Patients diagnosed as functional constipation according to the Rome IV criteria
- Informed consent of patients
Exclusion Criteria12
- 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
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Interventions
Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging
at least 3 months of continuous regular treatment. This treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.
Fluoxetine oral treatment for 4 weeks.
Locations(3)
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NCT06221722