Crohn Disease
Conditions
Keywords
fecal microbiota transplantation , Crohn Disease
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
Detailed description
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).
Interventions
OTHERStandardized FMT
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Sponsors
Biao Zou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Partial enteral nutrition,FMT
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission | 8-12 weeks after FMT | Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10 |
| Endoscopic remission | 8-12 weeks after FMT | Endoscopic remission defined by a Simple Endoscopic Score for CD （SES-CD) ≤ 2 |
| Mucosal healing | 8-12 weeks after FMT | Mucosal healing defined as SES-CD = 0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events | 2 and 8 weeks after FMT | All possible adverse events:fever,abdominal pain,infectious diseases and others |
Countries
China
Contacts
CONTACTBiao Zou, doctor
CONTACTSainan Shu, MD, PhD
STUDY_DIRECTORSainan Shu, MD, PhD
Tongji Hospital
Outcome results
None listed