Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:
• 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)
Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Biao Zou, doctor
464021552@qq.com
027-83663594
Backup
Sainan Shu, MD, PhD
shusainan@163.com
027-83663594
Time Frame
Start Date: 2022-03-22
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 40
Treatments
Experimental: Repeated and multiple FMTs plus PEN
repeated and multiple FMTs plus PEN(50% of total calories as polymeric diet, Peptamen, Nestle, Vevey, Switzerland) in refractory pediatric CD
Related Therapeutic Areas
Sponsors
Leads: Biao Zou