FMT: Fecal Microbiota Transplantation in Pediatric Ulcerative Colitis (UC)
Study Details
Study Description
Brief Summary
This study included two topics: one was to test the safety and efficacy of repeated and multiple fecal microbiota transplants (FMTs) plus partial enteral nutrition (PEN) in refractory pediatric UC where conventional therapy has failed, and the other was to explore the safety and efficacy of repeated and multiple FMTs plus PEN as first-line therapy for pediatric active UC
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
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 repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC. In the induction stage of UC, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 2 courses, 6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 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).
As a first-line treatment group for UC, our study is aims to repeated and multiple FMTs plus PEN as a first-line treatment for active UC in children. Patients treated with FMT coupled with PEN were defined as the FMT group, and those treated with PEN alone served as the PEN group. In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT was given 2 courses,6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 times of FMT treatment for each course.
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: FMT group In the refractory ulcerative colitis group, our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric UC; As a first-line treatment group for UC, repeated and multiple FMTs plus PEN as a first-line treatment for active UC in children. |
Other: Fecal Microbiota Transplantation
In the induction stage of UC, FMT group received FMT and PEN intervention, and FMT was given 2 courses,6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3 times of FMT treatment for each course. 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.
Other Names:
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Outcome Measures
Primary Outcome Measures
- clinical response [12 weeks after FMT]
reduction in the Pediatric Ulcerative Colitis Activity Index (PUCAI) ≥30% from baseline
- clinical remission [12 weeks after FMT]
Clinical remission defined as a PUCAI <10
- safety of FMT [12 weeks after FMT]
All possible adverse events: fever, abdominal pain, infectious diseases and others.
Secondary Outcome Measures
- Number of patients requiring escalation of medical therapies [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 [12 weeks after FMT]
Number of patients with endoscopic remission as defined by a PUCAI score of 0
- Fecal calprotectin level [12 weeks after FMT]
Mean change of Fecal calprotectin levels
- C-reactive protein levels [12 weeks after FMT]
Mean change of C-reactive protein levels
- erythrocyte sedimentation rate (ESR) level [12 weeks after FMT]
Mean change of erythrocyte sedimentation rate (ESR)
- The number of stools or bloody stools [12 weeks after FMT]
Improvement in the number of stools or bloody stools
- gut microbial [12 weeks after FMT]
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.
Eligibility Criteria
Criteria
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 PCDAI of >10 and≤30); In the refractory ulcerative colitis group, all refractory pediatric with mild-to-moderate UC (defined by the PCDAI of >10 and≤30) 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 and enema; Unwilling to give informed consent/ assent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Tongji Hospital | Wuhan | China | 430030 |
Sponsors and Collaborators
- Biao Zou
Investigators
- Study Director: Zhihua Huang, Tongji Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 63639979