Repeated and Multiple Fecal Microbiota Transplantations Plus Partial Enteral Nutrition as the First-line Treatment in Active Pediatric Crohn's Disease
Status: Recruiting
Location: See location...
Intervention Type: Drug, Biological
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
China
Tongji Hospital
RECRUITING
Wuhan
Contact Information
Primary
Biao Zou, MD
464021552@qq.com
15871365900
Backup
Sainan Shu, MD, PhD
shusainan@163.com
13886011908
Time Frame
Start Date: 2020-03-22
Estimated Completion Date: 2027-06-30
Participants
Target number of participants: 50
Treatments
Active_comparator: FMT group
Repeated and multiple FMTs plus PEN(80%) in the treatment of pediatric CD. Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) and FMT intervention. In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
Sham_comparator: Immunosuppressive group
Patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) combined with Immunosuppressants (hormones, azathioprine, thalidomide) treatment.
Related Therapeutic Areas
Sponsors
Leads: Tongji Hospital