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Recruiting NCT06221722

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

— Observational Constipation - Functional Refractory Constipation Fluoxetine fMRI

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BOLD-fMRI, Regular treatment of functional constipation, fluoxetine.
Who it may be relevant to
Registry conditions: Constipation - Functional, Refractory Constipation, Fluoxetine, fMRI. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Diagnostic test BOLD-fMRI
    Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging
  • Drug 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.
  • Drug fluoxetine
    Fluoxetine oral treatment for 4 weeks.

Primary outcome measures

  • Brain functional connectivity changes in BOLD-fMRI examination in refractory constipation before and after fluoxetine treatment [Time frame: 1-week pre and 4-week post of fluoxetine treatment]
Secondary outcome measures (5)
  • Changes in PAC-QOL self-assessment scores from baseline [Time frame: 1-week pre and 4-week post-fluoxetine treatment.]
  • Changes in PHQ-15 self-assessment scores relative to baseline. [Time frame: 1-week pre and 4-week post-fluoxetine treatment.]
  • Changes in GAD-7 self-assessment scores from baseline. [Time frame: 1-week pre and 4-week post-fluoxetine treatment.]
  • Changes in PHQ-9 self-assessment scores since baseline. [Time frame: 1-week pre and 4-week post-fluoxetine treatment.]
  • Changes in KESS self-assessment scores from baseline. [Time frame: 1-week pre and 4-week post-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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

China · 3 centers
  • People's Hospital of Ningxia Hui Autonomous Region — Yinchuan
  • Xi'an International Medical Center Hospital — Xi'an
  • Xijing Hospital, Fourth Military Medical University — Xi'an

Identifiers

NCT: NCT06221722 · KY20232332-C-1

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗