Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Xijing Hospital of Digestive Diseases

Status

Enrolling

Conditions

Somatic Symptom

Constipation - Functional

fMRI

Mental Symptom

Treatment Efficacy

Fluoxetine

Refractory Constipation

Brain Connectivity

Treatments

Drug: fluoxetine

Drug: Regular treatment of functional constipation

Diagnostic Test: BOLD-fMRI

Study type

Observational

Funder types

Other

Identifiers

NCT06221722

KY20232332-C-1

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

150 participants in 4 patient groups

Refractory constipation: fluoxetine sensitive

Description:

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.

Treatment:

Drug: fluoxetine

Drug: Regular treatment of functional constipation

Diagnostic Test: BOLD-fMRI

Refractory constipation: fluoxetine insensitive

Description:

Treatment:

Drug: fluoxetine

Drug: Regular treatment of functional constipation

Diagnostic Test: BOLD-fMRI

Non-refractory constipation

Description:

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.

Treatment:

Drug: Regular treatment of functional constipation

Diagnostic Test: BOLD-fMRI

Health Control

Description:

Volunteers without symptoms of constipation

Treatment:

Diagnostic Test: BOLD-fMRI