NCT06221722 Predicting Treatment Outcomes in Refractory Constipation Through Brain Connectivity Evaluation
| NCT ID | NCT06221722 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Xijing Hospital of Digestive Diseases |
| Condition | Constipation - Functional |
| Study Type | OBSERVATIONAL |
| Enrollment | 150 participants |
| Start Date | 2023-11-01 |
| Primary Completion | 2025-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 150 participants in total. It began in 2023-11-01 with a primary completion date of 2025-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Contact & Investigator
Qingchuan Zhao, Prof.
STUDY CHAIR
Xijing Hospital of Digestive Diseases
Frequently Asked Questions
Who can join the NCT06221722 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 45 Years, studying Constipation - Functional. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06221722 currently recruiting?
Yes, NCT06221722 is actively recruiting participants. Contact the research team at zhaozhifeng@outlook.com for enrollment information.
Where is the NCT06221722 trial being conducted?
This trial is being conducted at Yinchuan, China, Xi'an, China, Xi'an, China.
Who is sponsoring the NCT06221722 clinical trial?
NCT06221722 is sponsored by Xijing Hospital of Digestive Diseases. The principal investigator is Qingchuan Zhao, Prof. at Xijing Hospital of Digestive Diseases. The trial plans to enroll 150 participants.