Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation

Constipation - Functional Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06221722
• Other study ID #: KY20232332-C-1
• Status: Recruiting
• Start date: November 1, 2023
• Est. completion date: September 1, 2026

Study information

• Verified date: January 2024
• Source: Xijing Hospital of Digestive Diseases
• Contact: Zhifeng Zhao
• Phone: 13519171072
• Email: zhaozhifeng[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 1, 2026
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Connectivity
• Constipation
• Constipation - Functional
• Fluoxetine
• fMRI
• Medically Unexplained Symptoms
• Somatic Symptom
• Treatment Efficacy

Intervention

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.
• fluoxetine
Fluoxetine oral treatment for 4 weeks.

Locations

Country	Name	City	State
China	Xi'an International Medical Center Hospital	Xi'an	Shaanxi
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi
China	People's Hospital of Ningxia Hui Autonomous Region	Yinchuan	Ningxia

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital of Digestive Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Changes in PAC-QOL self-assessment scores from baseline	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.
Secondary	Changes in PHQ-15 self-assessment scores relative to baseline.	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.
Secondary	Changes in GAD-7 self-assessment scores from baseline.	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.
Secondary	Changes in PHQ-9 self-assessment scores since baseline.	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.
Secondary	Changes in KESS self-assessment scores from baseline.	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.