Tongji Hospital
Wuhan, Hubei, 430030, China
Location status: Recruiting
Location contact
Biao Zou, doctor
CONTACT
Sainan Shu, PhD
CONTACT
NCT Number: NCT05321745
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
Interested in participating?
Request Info2 year–16 year
All sexes
Interventional
Not applicable
Wuhan, Hubei, 430030, China
Location status: Recruiting
Biao Zou, doctor
CONTACT
Sainan Shu, PhD
CONTACT
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).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Fecal microbiota transplantation of fresh bacteria from healthy donor to the whole colon
Other names: Fecal Microbiota Transplantation
Time frame: 8-12 weeks after FMT
Clinical remission defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score≤10
Time frame: 8-12 weeks after FMT
Endoscopic remission defined by a Simple Endoscopic Score for CD (SES-CD) ≤ 2
Time frame: 8-12 weeks after FMT
Mucosal healing defined as SES-CD = 0
Time frame: 2 and 8 weeks after FMT
All possible adverse events:fever,abdominal pain,infectious diseases and others
Time frame: before treatment and 4-8 weeks after treatment
Fecal 16S RNA or macrogene sequencing was performed. Fecal samples were obtained from donor and recipient. The fecal samples and isolated microbiota samples were frozen immediately and underwent DNA extraction using standard methods.
Contact information is provided by the study sponsor or research team.
Biao Zou, doctor
CONTACT
Sainan Shu, MD, PhD
CONTACT
Biao Zou
Other
Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
Acronym: FMT
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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