Ulcerative Colitis
Conditions
Keywords
Fecal microbiota transplantation, Ulcerative Colitis
Brief summary
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
Detailed description
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.
Interventions
OTHERFecal Microbiota Transplantation
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.
Sponsors
Biao Zou
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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; 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| clinical response | 8-12 weeks after FMT | reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline |
| clinical remission | 8-12 weeks after FMT | Clinical remission defined as a PUCAI \<10 |
| safety of FMT | 8-12 weeks after FMT | All possible adverse events: fever, abdominal pain, infectious diseases and others. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients requiring escalation of medical therapies | 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. |
| Number of patients with endoscopic remission | 8-12 weeks after FMT | Number of patients with endoscopic remission as defined by a PUCAI score of 0 |
| Fecal calprotectin level | 8-12 weeks after FMT | Mean change of Fecal calprotectin levels |
| C-reactive protein levels | 8-12 weeks after FMT | Mean change of C-reactive protein levels |
| erythrocyte sedimentation rate (ESR) level | 8-12 weeks after FMT | Mean change of erythrocyte sedimentation rate (ESR) |
| The number of stools or bloody stools | 8-12 weeks after FMT | Improvement in the number of stools or bloody stools |
| gut microbial | 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. |
Countries
China
Contacts
CONTACTBiao Zou
CONTACTSainan Shu, MD, PhD
STUDY_DIRECTORZhihua Huang
Tongji Hospital
Outcome results
None listed