Tongji Hospital
Wuhan, 430030, China
Location status: Recruiting
Location contact
Biao Zou
CONTACT
Sainan Shu, professor
CONTACT
NCT Number: NCT05679622
This study included two topics: one was to test the efficacy and safety of fecal microbiota transplants plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the efficacy and safety of FMT plus PEN as first-line therapy for pediatric active UC
Interested in participating?
Request Info2 year–16 year
All sexes
Interventional
Not applicable
Wuhan, 430030, China
Location status: Recruiting
Biao Zou
CONTACT
Sainan Shu, professor
CONTACT
Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of UC, and that FMT could be a useful treatment. In the refractory ulcerative colitis group, our study is aims to explore FMT plus PEN in the treatment of refractory pediatric UC. In the induction stage of UC, standard therapy remained unchanged, FMT and PEN treatment are added, and the investigators hope the withdrawal of conventional drug therapy was gradually reduced. Refractory UC is defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).
As a first-line treatment group for UC, our study is aims to explore FMT plus PEN as a first-line treatment for active UC in children. participants treated with FMT coupled with PEN are defined as the FMT group, and those treated with PEN coupled with mesalazine served as the PEN group.
FMT treatment is given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval.
All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
age of older than 2 years and younger than 16 years with no genetic diseases; as a first-line treatment group for UC, newly diagnosed with mild-to-moderate UC (defined by the PUCAI of >10 and≤64); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PUCAI of >10 and≤64) defined by children who failed conventional treatment (hormone, immunosuppressant, biologics); agree to received regularly colonoscopy
Exclusion criteria
Children who were treated by PEN (80%) less than 8 weeks; As a first-line treatment group for UC, patients who were treated with corticosteroids, methotrexate, thiopurines, and anti-TNF agents as their first-line treatment; 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
In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT group are given for at least one course of FMT treatment. If repeated FMTs are received, it is usually at a 2 month interval. All the participants received PEN (80% of total calories as a polymeric diet, Peptamen, Nestle, Vevey, and Switzerland) intervention to help induce and maintain clinical remission.
Time frame: 8-12 weeks after FMT
reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
Time frame: 8-12 weeks after FMT
Clinical remission defined as a PUCAI <10
Time frame: 8-12 weeks after FMT
All possible adverse events: fever, abdominal pain, infectious diseases and others.
Time frame: 8-12 weeks after FMT
Number of patients requiring escalation of medical therapies based on clinical relapse. Clinical relapse is defined by requiring additional medical therapy.
Time frame: 8-12 weeks after FMT
Number of patients with endoscopic remission as defined by a PUCAI score of 0
Time frame: 8-12 weeks after FMT
Mean change of Fecal calprotectin levels
Time frame: 8-12 weeks after FMT
Mean change of C-reactive protein levels
Time frame: 8-12 weeks after FMT
Mean change of erythrocyte sedimentation rate (ESR)
Time frame: 8-12 weeks after FMT
Improvement in the number of stools or bloody stools
Time frame: before treatment and 4 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
CONTACT
Sainan Shu, MD, PhD
CONTACT
Biao Zou
Other
Repeated and Multiple Fecal Microbiota Transplantations in Active Pediatric Ulcerative Colitis (UC)
Acronym: FMT
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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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