Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-01

Study Completion Date

2026-09-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Constipation - Functional Refractory Constipation Fluoxetine fMRI Brain Connectivity Treatment Efficacy Somatic Symptom Mental Symptom

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Refractory constipation: fluoxetine sensitive

Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.

After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with effective treatment of constipation symptoms.

BOLD-fMRI

Intervention Type DIAGNOSTIC_TEST

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Regular treatment of functional constipation

Intervention Type DRUG

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

Intervention Type DRUG

Fluoxetine oral treatment for 4 weeks.

Refractory constipation: fluoxetine insensitive

Functional constipation patients maintained at least 3 months of continuous regular therapy with ineffective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.

After 3 months of regular treatment, patients received fluoxetine therapy for 4-week with ineffective treatment of constipation symptoms.

BOLD-fMRI

Intervention Type DIAGNOSTIC_TEST

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Regular treatment of functional constipation

Intervention Type DRUG

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

Intervention Type DRUG

Fluoxetine oral treatment for 4 weeks.

Non-refractory constipation

Functional constipation patients maintained at least 3 months of continuous regular therapy with effective treatment. The treatment included the utilization of osmotic laxatives, stimulant laxatives, prosecretory agents, and a high-fibre diet.

BOLD-fMRI

Intervention Type DIAGNOSTIC_TEST

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Regular treatment of functional constipation

Intervention Type DRUG

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.

Health Control

Volunteers without symptoms of constipation

BOLD-fMRI

Intervention Type DIAGNOSTIC_TEST

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Interventions

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BOLD-fMRI

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DRUG

fluoxetine

Fluoxetine oral treatment for 4 weeks.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes