NCT05321745 Fecal Microbiota Transplantation in Pediatric Crohn's Disease
| NCT ID | NCT05321745 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biao Zou |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2022-03-22 |
| Primary Completion | 2027-05-31 |
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 40 participants in total. It began in 2022-03-22 with a primary completion date of 2027-05-31.
⚠ 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 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
Eligibility Criteria
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
Contact & Investigator
Sainan Shu, MD, PhD
STUDY DIRECTOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT05321745 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 NCT05321745 currently recruiting?
Yes, NCT05321745 is actively recruiting participants. Contact the research team at 464021552@qq.com for enrollment information.
Where is the NCT05321745 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05321745 clinical trial?
NCT05321745 is sponsored by Biao Zou. The principal investigator is Sainan Shu, MD, PhD at Tongji Hospital. The trial plans to enroll 40 participants.