Crohn Disease
Conditions
Keywords
Crohn Disease;fecal microbiota transplantation
Brief 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.
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 as a first-line treatment for active Crohn's disease (CD) in children. The patients were divided into 2 groups voluntarily. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN combined with Immunosuppressants (hormones, azathioprine, thalidomide) served as the Immunosuppressive group. The therapeutic effect of the two groups was compared. In the induction stage of CD, FMT group received FMT and PEN intervention, and FMT was given 1-3 courses, 3-6 times per course. The transplantation routes include oral capsule, enema and/or colonoscopy. All the patients received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Interventions
BIOLOGICALFecal Microbiota Transplantation
In the induction stage of CD, FMT was given 1-3 courses, 3-6 times per course.
DRUGImmunosuppressive Agents
hormones, azathioprine, thalidomide
Sponsors
Tongji Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Partial enteral nutrition,FMT
Eligibility
Sex/Gender
ALL
Age
2 Years to 16 Years
Healthy volunteers
Yes
Inclusion criteria
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
Exclusion criteria
patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment
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 10 weeks after FMT | All possible adverse events:fever,abdominal pain,infectious diseases and others |
Countries
China
Contacts
CONTACTBiao Zou, MD
CONTACTSainan Shu, MD, PhD
STUDY_DIRECTORZhihua Huang
Tongji Hospital
Outcome results
None listed