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NCT Number: NCT06221722

Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

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.

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Key information

Conditions

Constipation - Functional Brain Connectivity Constipation Fluoxetine Medically Unexplained Symptoms Mental Symptom Pathological Conditions, Signs and Symptoms Refractory Constipation Signs and Symptoms Signs and Symptoms, Digestive Somatic Symptom Treatment Efficacy fMRI

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

People's Hospital of Ningxia Hui Autonomous Region, Yinchuan, Ningxia, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BOLD-fMRI

Diagnostic Test

Blood-Oxygen-Level Dependent Functional Magnetic Resonance Imaging

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.

Fluoxetine

Drug

Fluoxetine oral treatment for 4 weeks.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Zhifeng Zhao

CONTACT

[email protected]

13519171072

Sponsors and collaborators

Lead sponsor

Xijing Hospital of Digestive Diseases

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Jan 24, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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