NCT07261826 Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
| NCT ID | NCT07261826 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Chen QiYi |
| Condition | Clostridium Difficile Infection Recurrence |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2028-06-30 |
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 4,000 participants in total. It began in 2025-09-01 with a primary completion date of 2028-06-30.
⚠ 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
This is a large-scale observational study aiming to evaluate the long-term effectiveness and safety of Fecal Microbiota Transplantation (FMT). FMT is a procedure that transfers gut bacteria from healthy donors to patients to restore a balanced gut microbiome. The study will follow approximately 4,000 patients who have received or will receive FMT for conditions like recurrent C. difficile infection, inflammatory bowel disease, functional gastrointestinal disorders, and certain neurological conditions. The main goals are to: * Assess the disease remission rates at 3 months, 1 year, and 5 years after FMT. * Monitor the long-term safety and any potential side effects. * Identify factors that may influence how well a patient responds to the treatment. This research will use both existing patient data (retrospective cohort) and newly collected data from future patients (prospective cohort). The findings are expected to help improve and standardize FMT treatment for better patient care.
Eligibility Criteria
Inclusion Criteria: * Diagnosed with one of the target diseases. * Age ≥ 3 years. * Have received at least one Fecal Microbiota Transplantation (FMT) treatment. * Availability of complete baseline and follow-up data for analysis. * Provide signed informed consent (for the prospective cohort) OR consent for the use of clinical data (for the retrospective cohort). Exclusion Criteria: * Clinical data is severely missing, making efficacy assessment impossible. * Presence of severe complications that may jeopardize safety or confound the study results.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07261826 clinical trial?
This trial is open to participants of all sexes, aged 3 Years or older, studying Clostridium Difficile Infection Recurrence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07261826 currently recruiting?
Yes, NCT07261826 is actively recruiting participants. Contact the research team at qiyichen2011@163.com for enrollment information.
Where is the NCT07261826 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07261826 clinical trial?
NCT07261826 is sponsored by Chen QiYi. The trial plans to enroll 4,000 participants.