Crohn Disease, Irritable Bowel, Irritable Bowel Syndrome, Ulcerative Colitis
Conditions
Brief summary
Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.
Detailed description
Objectives of the study: 1. To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. 2. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. 3. Create a bank of fecal samples of healthy donors; 4. Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers; 5. Analyze the efficacy of therapy with TFM on the sample of patients; 6. Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers; 7. Analyze long-term effects in patients within 6 months after the TPM. The study is expected to include 50 patients, 35 healthy volunteers and healthy feces donors The study is scheduled to begin in May 2018, the supposed completion of the study is December 2020
Interventions
OTHERFecal Microbiota Transplantation
Fecal Microbiota Transplantation
Sponsors
Federal Research and Clinical Center of Physical-Chemical Medicine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
In total, 85 participants must be registered. 35 are healthy volunteers. Of these volunteers, 15 will receive autologous transplantation of fecal microbiota, 10 will receive both autologous and heterologous transplantation and 10 volunteers form a placebo-controlled group. 50 participants will form a treatment group.
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* the age of patients - from 18 to 75 years, both sexes; * Patients with: * antibiotic-associated colitis, * inflammatory bowel diseases (ulcerative colitis, Crohn's disease), * diseases caused by C. difficile infection, * a syndrome of impaired intestinal absorption, * irritable bowel syndrome, * celiac disease (severe form), * metabolic syndrome, including diabetes mellitus type II, * Atopic dermatitis with damage to the mucous membrane of the colon, * hepatitis of various etiologies, * cirrhosis of the liver of various etiologies * pancreatitis of various etiologies, * Absence of contraindications to gastroscopy * informed consent of the patient for the transplant procedure
Exclusion criteria
* the presence of a concomitant chronic infectious or neoplastic disease in the patient * Patients with a proven allergy to foods not excluded from the donor's diet * absence of the patient for one or more intermediate stages of the examination. * informed refusal to continue therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ulcerative Colitis remission | 1 month after transplantation. Change from Baseline - 1 day before transplantation | Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index \<3 |
| Crohn Disease remission | 1 month after transplantation. Change from Baseline - 1 day before transplantation. | Crohn Disease remission defined as a Harvey-bradshaw index \<3. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Ulcerative Colitis symptoms. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. | Defined as improvement in SCCAI. |
| Change in gut microbiome | 1 month after transplantation. Change from Baseline - 1 day before transplantation. | Diversity and variability of gut microbiome. |
Countries
Russia
Outcome results
None listed