Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

NCT06221722 | Recruiting DMC

• 1 other identifier: KY20232332-C-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

fMRI; functional connectivity; refractory constipation

Outcome Measures

Primary Outcomes (1)

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

  BOLD-fMRI tests before and after fluoxetine treatment

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

Secondary Outcomes (5)

• Changes in PAC-QOL self-assessment scores from baseline

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

• Changes in PHQ-15 self-assessment scores relative to baseline.

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

• Changes in GAD-7 self-assessment scores from baseline.

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

• Changes in PHQ-9 self-assessment scores since baseline.

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

• Changes in KESS self-assessment scores from baseline.

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

Study Arms (4)

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.

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

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.

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

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.

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

Health Control

Volunteers without symptoms of constipation

Diagnostic Test: BOLD-fMRI

Interventions

BOLD-fMRI DIAGNOSTIC_TEST

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

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

Regular treatment of functional constipation 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.

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

fluoxetine DRUG

Fluoxetine oral treatment for 4 weeks.

Refractory constipation: fluoxetine insensitive; Refractory constipation: fluoxetine sensitive

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

tertiary hospitals received patients from northwest of China

You may qualify if:

• ≤ age ≤ 45 years old
• Right-handed
• Patients diagnosed as functional constipation according to the Rome IV criteria
• Informed consent of patients

You may not qualify if:

• 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

Sponsors & Collaborators

• Xijing Hospital of Digestive Diseases: lead

Study Sites (3)

People's Hospital of Ningxia Hui Autonomous Region

Yinchuan, Ningxia, 750002, China

RECRUITING

Xi'an International Medical Center Hospital

Xi'an, Shaanxi, 710032, China

RECRUITING

Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, 710032, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Stool, Blood

MeSH Terms

Conditions

Constipation; Medically Unexplained Symptoms

Interventions

Fluoxetine

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals

Study Officials

• Qingchuan Zhao, Prof.

  Xijing Hospital of Digestive Diseases

  STUDY CHAIR

Central Study Contacts

Zhifeng Zhao

CONTACT

13519171072; zhaozhifeng@outlook.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: December 26, 2023
• First Posted: January 24, 2024
• Study Start: November 1, 2023
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
• Access Criteria: For more information or to submit a request, please contact zhaozhifeng@outlook.com.

Locations

CN (3)