Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
Not applicable · Testing Fecal Microbiota Transplantation and Immunosuppressive Agents · 1 site · Tongji Hospital
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Fecal Microbiota Transplantation (a biologic) and Immunosuppressive Agents (a drug) 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
- Healthy volunteers accepted
Some of the main requirements, copied from the record:
- age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week…
There are also 1 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 50 participants are expected to take part.
- Start date: 2020-03-22.
- Main results expected around 2027-06-30 (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
To explore the safety and effectiveness of repeated and multiple fecal microbiota transplantations (FMTs) plus partial enteral nutrition (PEN) as a first-line treatment for active Crohn's disease (CD) in children.
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 | Tongji Hospital |
| Enrollment | 50 (estimated) |
| Start date | 2020-03-22 |
| Primary completion (est.) | 2027-06-30 |
| First posted | 2022-04-11 |
| Last updated | 2026-07-10 |
| Official title | Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease |
| ClinicalTrials.gov ID | NCT05321758 |
Interventions
- Fecal Microbiota Transplantation (Biological)
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course. - Immunosuppressive Agents (Drug)
hormones, azathioprine, thalidomide
Full eligibility criteria (from the record)
Inclusion Criteria: age of older than 2 years and younger than 16 years with no genetic diseases; newly diagnosed with mild-to-moderate CD ( defined by the PCDAI of >10 and ≤40, and SES-CD of >3); Subjects with no change in medication or dose at least 1 week prior to transplantation; agree to received regularly colonoscopy Exclusion Criteria: patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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.