Clinical trial

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

Name

KY20232332-C-1

Description

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.

Trial arms

Trial start

2023-11-01

Estimated PCD

2025-09-01

Trial end

2026-09-01

Status

Recruiting

Treatment

BOLD-fMRI

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Arms:

Health Control, Non-refractory constipation, Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive

Regular treatment of functional constipation

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.

Arms:

Non-refractory constipation, Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive

fluoxetine

Fluoxetine oral treatment for 4 weeks.

Arms:

Refractory constipation: fluoxetine insensitive, Refractory constipation: fluoxetine sensitive

Size

150

Primary endpoint

Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment

1-week pre and 4-week post of fluoxetine treatment

Eligibility criteria

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

Protocol

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Updated at

2024-01-30

1 organization

2 products

8 indications

Organization

Xijing Hospital of Digestive Diseases

Product

Regular treatment of functional constipation

Indication

Constipation

Indication