Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

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Xijing Hospital of Digestive Diseases

Status

Enrolling

Conditions

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

Treatments

Drug: Regular treatment of functional constipation
Diagnostic Test: BOLD-fMRI
Drug: fluoxetine

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
Diagnostic Test: BOLD-fMRI
Drug: Regular treatment of functional constipation
Refractory constipation: fluoxetine insensitive
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 ineffective treatment of constipation symptoms.
Treatment:
Drug: fluoxetine
Diagnostic Test: BOLD-fMRI
Drug: Regular treatment of functional constipation
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:
Diagnostic Test: BOLD-fMRI
Drug: Regular treatment of functional constipation
Health Control
Description:
Volunteers without symptoms of constipation
Treatment:
Diagnostic Test: BOLD-fMRI

Trial contacts and locations

3

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Central trial contact

Zhifeng Zhao

Data sourced from clinicaltrials.gov

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