NCT05321758 Fecal Microbiota Transplantation as the First-line Treatment in Active Pediatric Crohn's Disease
| NCT ID | NCT05321758 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Tongji Hospital |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2020-03-22 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2020-03-22 with a primary completion date of 2027-06-30.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Zhihua Huang
STUDY DIRECTOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT05321758 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05321758 currently recruiting?
Yes, NCT05321758 is actively recruiting participants. Contact the research team at 464021552@qq.com for enrollment information.
Where is the NCT05321758 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05321758 clinical trial?
NCT05321758 is sponsored by Tongji Hospital. The principal investigator is Zhihua Huang at Tongji Hospital. The trial plans to enroll 50 participants.