Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Not applicable · Testing Standardized FMT · 1 site · Biao Zou
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Standardized FMT as a possible treatment. Condition(s) listed: Crohn Disease.
It is open-label: participants know what they are receiving.
This study does not use drug-development phases (it may test a device, diet, procedure, app, or care approach).
Who can join
- Ages 2 to 16
- Any sex
Some of the main requirements, copied from the record:
- Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) >10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) >…
Only the trial team can confirm whether you qualify.
What's involved
- About 40 participants are expected to take part.
- Start date: 2022-03-22.
- Main results expected around 2027-05-31 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Clinical remission (8-12 weeks after FMT)
In the researchers’ words
This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment
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 | Not applicable |
| Study type | Interventional |
| Conditions | Crohn Disease |
| Lead sponsor | Biao Zou |
| Enrollment | 40 (estimated) |
| Start date | 2022-03-22 |
| Primary completion (est.) | 2027-05-31 |
| First posted | 2022-04-11 |
| Last updated | 2026-07-10 |
| Official title | Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease |
| ClinicalTrials.gov ID | NCT05321745 |
Interventions
- Standardized FMT (Other)
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Full eligibility criteria (from the record)
Inclusion Criteria: Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) >10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) > 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics) Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Tongji Hospital | Wuhan, Hubei | 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.