Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

July 22, 2025 updated by: Zhifeng Zhao, PhD, Xijing Hospital of Digestive Diseases

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750002
        • Recruiting
        • People's Hospital of Ningxia Hui Autonomous Region
        • Contact:
        • Principal Investigator:
          • Xuzhao Li
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital, Fourth Military Medical University
        • Principal Investigator:
          • Bin Yang
        • Contact:
        • Sub-Investigator:
          • Zhifeng Zhao
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xi'an International Medical Center Hospital
        • Contact:
        • Principal Investigator:
          • Qinxian Huang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

tertiary hospitals received patients from northwest of China

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.
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
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.
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
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.
Health Control
Volunteers without symptoms of constipation
Diagnostic test: BOLD-fMRI
Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
BOLD-fMRI tests before and after fluoxetine treatment
1-week pre and 4-week post of fluoxetine treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in PAC-QOL self-assessment scores from baseline
Time Frame: 1-week pre and 4-week post-fluoxetine treatment.
The Patient Assessment of Constipation Quality of Life (PAC-QOL) questionnaire is a self-reported instrument designed to measure the quality of life in individuals with constipation. This tool comprises 28 items across four fundamental domains, including physical discomfort, worries and concerns, psychosocial discomfort, and satisfaction. In our study, the Chinese version (version 16) was utilized.
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.
The Patient Health Questionnaire-15 (PHQ-15) is a self-reporting inventory that evaluates the severity of somatic symptoms in patients. Comprising 15 items, the questionnaire primarily focuses on experienced bodily symptoms and aids healthcare providers in identifying potential somatization disorders or severe somatic illnesses.
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.
The Generalized Anxiety Disorder-7 (GAD-7) is a brief measure assessing the frequency of anxiety symptoms over the past two weeks. With 7 items, the scale concentrates on the core symptoms of generalized anxiety disorder, serving as an instrument to ascertain the level of anxiety and to monitor the improvement of anxiety symptoms.
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.
The Patient Health Questionnaire-9 (PHQ-9) is a tool used for screening, diagnosing, monitoring, and quantifying the severity of depression. The questionnaire consists of 9 items drawing from typical symptoms of depression, facilitating the evaluation of the presence and severity of depression by medical professionals.
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.
The KESS questionnaire, Kovacs' Evaluation of Sphincter Symptoms, is utilized to assess defecatory dysfunction. It includes a series of items that inquire about constipation symptoms and defecatory habits, aiming to evaluate the severity and impact of a patient's defecatory disorders.
1-week pre and 4-week post-fluoxetine treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital of Digestive Diseases

Investigators

  • Study Chair: Qingchuan Zhao, Prof., Xijing Hospital of Digestive Diseases

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

December 26, 2023

First Submitted That Met QC Criteria

January 14, 2024

First Posted (Actual)

January 24, 2024

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 22, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20232332-C-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Access to trial IPD can be requested by qualified researchers engaging in independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information or to submit a request, please contact zhaozhifeng@outlook.com.

IPD Sharing 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.

IPD Sharing Access Criteria

For more information or to submit a request, please contact zhaozhifeng@outlook.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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