NCT05679622 Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
| NCT ID | NCT05679622 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Biao Zou |
| Condition | Ulcerative Colitis |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2022-12-01 |
| Primary Completion | 2026-06-30 |
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 30 participants in total. It began in 2022-12-01 with a primary completion date of 2026-06-30.
⚠ 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
This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC
Eligibility Criteria
Inclusion Criteria: age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of \>10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy Exclusion Criteria: Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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
Zhihua Huang
STUDY DIRECTOR
Tongji Hospital
Frequently Asked Questions
Who can join the NCT05679622 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 16 Years, studying Ulcerative Colitis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05679622 currently recruiting?
Yes, NCT05679622 is actively recruiting participants. Contact the research team at 464021552@qq.com for enrollment information.
Where is the NCT05679622 trial being conducted?
This trial is being conducted at Wuhan, China.
Who is sponsoring the NCT05679622 clinical trial?
NCT05679622 is sponsored by Biao Zou. The principal investigator is Zhihua Huang at Tongji Hospital. The trial plans to enroll 30 participants.
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