Inflammatory bowel disease
Conditions
Interventions
intervention group:Fecal microbiota transplant combined with exclusive enteral nutrition
Sponsors
Department of Colonrectal Disease, Shanghai Tenth people's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with IBD diagnosed by endoscopy and biopsy have a course of more than 3 months. Intestinal infection, mucosal dysplasia and / or malignant tumor were excluded. If the diagnosis is completed in another hospital, endoscopy and biopsy report should be provided. 2. Subjects aged 18-70 at baseline, regardless of gender. 3. Subjects with active inflammation: (1) CDAI > 200, ses-cd score >= 7 in CD patients; (2) The Mayo score of UC patients ranged from 4 to 9, and the Mayo endoscopic score was >= 2. 4. Subjects who did not respond to the following treatment regimens were found to be unresponsive or intolerant: (1) The symptoms and signs of persistent disease activity were observed after oral administration of aminosalicylic acid for 4 weeks. (2) intravenous use of prednisone 40mg for a week still has symptoms and signs of persistent disease activity, or relapse of disease during oral reduction, or there is a contraindication of hormone use (including * but not limited to necrosis of femoral head, infection, severe sodium retention). (3) The following immunosuppressive regimens were used up to 90 days: oral azathioprine (>= 1mg / kg / day), subcutaneous or intramuscular MTX (>= 15mg / week), oral tacrolimus and monitoring of blood trough concentration of 5-10ng / ml, with persistent disease active symptoms and signs; or intolerance to immunosuppressive agents (including but not limited to: pancreatitis, leucopenia, severe liver damage, infection, etc.) (4) After receiving at least one 6-week infliximab induction remission protocol (5mg / kg iv for 0, 2 and 6 weeks respectively), or completing the induction remission course of adalimumab, gollimumab, vidozumab and ulinumab in other countries and regions, there are still persistent symptoms and signs of disease activity; or intolerance to biological agents (including but not limited to active drugs) Intraperitoneal infection, infusion reaction, anti antibody production). 5. Subjects who signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who failed to make a definite diagnosis of inflammatory bowel disease. 2. Patients currently diagnosed with fulminant colitis / toxic megacolon. 3. Patients who can not tolerate total enteral nutrition due to significant fibrous intestinal stenosis, severe gastrointestinal bleeding, high flow intestinal fistula and other reasons. 4. Patients with severe systemic infection. 5. Patients with malignant tumor. 6. Patients with severe malnutrition (BMI < 15), severe hypoproteinemia (albumin < 25g), severe immunosuppression (neutrophils < 1500 / mm3, lymphocytes < 500 / mm3). 7. Patients who cannot tolerate nasojejunal tube insertion. 8. Pregnant or lactating women, women of childbearing age who are willing to give birth in the next six months. 9. Subjects who could not comply with the trial arrangement. 10. Other researchers think that it is not suitable to accept flora transplantation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease relieve;Disease relieve; | — |
Secondary
| Measure | Time frame |
|---|---|
| The recovery and maintenance of intestinal flora richness and diversity for 6 months after the 5th, 49th week and after the completion of the microbiota transplantation treatment;The improvement and maintenance of the intestinal microbiota metabolome were followed up for 6 months after the 5th, 49th week and the end of the flora transplantation treatment.;Clinical and endoscopic scores of disease activity followed up for 6 months after the completion of bacterial transplantation;Improvement and maintenance of nutritional status of patients in the 5th, 49th week and after the completion of microbial transplantation treatment for 6 months;Cost-effectiveness ratio of FMT combined with total enteral nutrition in the treatment of IBD; | — |
Countries
China
Contacts
Public ContactZhao Di
Department of Colonrectal Disease, Shanghai Tenth people's Hospital
Outcome results
None listed