Crohn's Disease, Inflammatory Bowel Disease, Ulcerative Colitis
Conditions
Keywords
Standardized Fecal Microbiota Transplantation, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease
Brief summary
There are many limitations in the current treatments of Inflammatory bowel disease (IBD). Now the investigators realized that the intestinal microecological is closely associated with the development of IBD. So the standardized fecal microbiota transplantation is considered to be simple but effective emerging therapies for the treatment of IBD. In this project the investigators intend to carry out a single-center, randomized, single-blind clinical intervention study. The investigators will recruit 40 patients with IBD (20 cases of Ulcerative Colitis and 20 cases of Crohn's disease) in China. The patients will be randomly divided into 2 groups, one group will be given treatment of standardized fecal microbiota transplantation, the other will be simply treated with mesalazine, followed up for at least 1 year. The investigators propose to determine the efficiency, durability and safety of Standardized Fecal Microbiota Transplantation for IBD treatment.
Detailed description
In this projects the investigators aim to re-establish a gut balance of intestinal microecological through Standardized Fecal Microbiota Transplantation for IBD (UC and CD). We will establish a standardized isolation, store, and transportion steps of fecal bacteria from donated fresh stool in the laboratory. Then the bacteria will be transplanted to mid-gut by nose-jejunum nutrition tube. Patients in this study will be assigned to receive standardized FMT only once or traditional medicine of mesalazine and would be followed up for at least 1 year. The clinical symptoms, sign, blood tests, abdominal CT, endoscopy and questionnaire will be used to assess the efficiency, durability and safety of Standardized FMT at the start and end of the projects.
Interventions
PROCEDUREFMT
Standardized FMT once
DRUGMesalazine
2g Po perday
Sponsors
Yanling Wei
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
16 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Severe IBD define as HBI score ≥ 9. * Moderate IBD define as 7\<HBI \<9 * Montreal classification: Age \> 14 years old, Location L1-3, Behavior B1-3.
Exclusion criteria
* Diarrhea activity scores \< 3 * Severely active disease with perianal diseases * Severely active disease with indication of surgery. * Diagnosis as IBD first time or first year. * No history of using 5-ASA, biological (antibody), immunomodulatory therapy, corticosteroid therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical remission (defined as HBI score ≦ 4) | up to one year | Clinical remission defined as HBI score ≦ 4. The endpoint of follow-up is the time of clinical recurrence |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization days | up to one year | Hospitalization days from administration to discharge when at clinical remission. |
Countries
China
Contacts
Primary ContactDongfeng Chen, doctor
Backup ContactYanling Wei, doctor
Outcome results
None listed