Fecal Microbiota Transplantation, Inflammatory Bowel Disease (Crohn&Amp;#39;s Disease and Ulcerative Colitis)
Conditions
Brief summary
This study enrolled 94 patients with UC or CD. Two groups received either 8-week intestinal bacterial transplant capsule therapy or biological therapy, respectively. The control group received biological therapy alone, while the experimental group received biological therapy combined with FMT. Both groups were followed up for 52 weeks after discharge. The efficacy of FMT capsule therapy on the subjects' UC or CD symptom-related scores and its effect on remodeling the intestinal flora were observed, and its safety was verified.
Interventions
PROCEDUREFecal microbiota transplantation
Fecal microbiota transplantation (FMT) achieves the purpose of treating intestinal and extra-intestinal diseases by transplanting the functional microbes in the feces of healthy people into the patient's intestine through the upper or lower alimentary tract routes to rebuild the patient's intestinal microbiota.
DRUGinfliximab
Intravenous infusion of infliximab once every 8 weeks.
Sponsors
Shanghai 10th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence. * IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases. * Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449) * Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved. * Voluntary participation and signing of informed consent. * Adults aged 18-65. * Can tolerate oral enterobacteria transplantation capsule treatment.
Exclusion criteria
* The diagnosis was UC or CD, and the diagnosis was based on clinical, endoscopic and pathological evidence. * IBD should be diagnosed for at least 6 months to rule out the possibility of natural remission of new cases. * Patients should be in mild to moderate active stage (UC: Mayo score 3-10; CD: CDAI score: 150-449) * Biological agents (such as anti-TNF-α drugs, vedolizumab, etc.) were used in the past, but no clinical remission was achieved. * Voluntary participation and signing of informed consent. * Adults aged 18-65. * Can tolerate oral enterobacteria transplantation capsule treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endoscopic remission rate | 14th and 52nd week after joining the group. | UC is endoscopic Mayo score 0-1; CD is simple endoscopic score (SES-CD)\<3 or no ulcer. |
| Clinical remission rate | 14th and 52nd week after joining the group. | UC is defined as Mayo score ≤2, and no single score \> 1; CD is defined as CDAI (Crohn's disease activity index) \< 150. |
Countries
China
Outcome results
None listed