Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics
Observational · No treatment assigned · 1 site · Chen QiYi
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Clostridium Difficile Infection Recurrence, Ulcerative Colitis (UC) and Crohn Disease (CD). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 3 and older
- Any sex
Some of the main requirements, copied from the record:
- Diagnosed with one of the target diseases.
- Age ≥ 3 years.
- Have received at least one Fecal Microbiota Transplantation (FMT) treatment.
Plus 2 more requirement(s). There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 4000 participants are expected to take part.
- Start date: 2025-09-01.
- Main results expected around 2028-06-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- 8-Week Clinical Cure of Recurrent CDI (8 weeks after the final FMT treatment)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Clostridium Difficile Infection Recurrence; Ulcerative Colitis (UC); Crohn Disease (CD); Irritable Bowel Syndrome (IBS); Chronic Functional Constipation; Chemotherapy-Induced Colitis; PD-1 Associated Enteritis; Autism Spectrum Disorder; Incomplete Intestinal Obstruction |
| Lead sponsor | Chen QiYi |
| Enrollment | 4000 (estimated) |
| Start date | 2025-09-01 |
| Primary completion (est.) | 2028-06-30 |
| First posted | 2025-12-03 |
| Last updated | 2025-12-03 |
| Official title | Real-World Study on Fecal Microbiota Transplantation: Long-Term Effectiveness and Safety Statistics |
| ClinicalTrials.gov ID | NCT07261826 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Tenth People's Hospital | Shanghai, Shanghai Municipality | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.