Evaluating brain connectivity in patients with refractory constipation
Evaluation of Brain Connectivity Function in Predicting Therapeutic Effects in Patients With Refractory Constipation: a Multicenter, Prospective, Cohort Study
This study is trying to see how brain activity in people with stubborn constipation can help predict if they will respond well to fluoxetine and other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | All |
| Sponsor | Xijing Hospital of Digestive Diseases Academic / other |
| Locations | 3 sites (Yinchuan, Ningxia and 2 other locations) |
| Trial ID | NCT06221722 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the characteristics of brain functional connectivity in patients suffering from refractory constipation and those who are sensitive to fluoxetine. It will assess how these brain connectivity patterns can predict the effectiveness of fluoxetine and standard treatments for constipation. Participants will undergo standard physiological and psychological assessments, as well as BOLD-fMRI tests to evaluate brain activity. The study will compare brain alterations between refractory constipation patients and fluoxetine-sensitive patients to identify potential biomarkers for treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are right-handed adults aged 18 to 45 diagnosed with functional constipation according to the Rome IV criteria.
Not a fit: Patients with gastrointestinal organic diseases, significant functional abnormalities, or those with a history of chronic pain or mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with refractory constipation by identifying predictive biomarkers.
How similar studies have performed: While there is ongoing research into brain connectivity and gastrointestinal disorders, this specific approach focusing on refractory constipation and fluoxetine sensitivity is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yinchuan, Ningxia and 2 other locations
- People's Hospital of Ningxia Hui Autonomous Region — Yinchuan, Ningxia, China (Recruiting)
- Xi'an International Medical Center Hospital — Xi'an, Shaanxi, China (Recruiting)
- Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)
Study contacts
- Study coordinator: Zhifeng Zhao
- Email: zhaozhifeng@outlook.com
- Phone: 13519171072
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.