Fecal Microbiota Transplantation for Health Improvement (TFM3)

Study Overview
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Brief Summary
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Search for mechanisms of the effect of fecal transplantation on a healthy organism and various nosological forms.

Detailed Description
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Objectives of the study: To select donors of fecal samples for carrying out the procedure of fecal transplantation of microbiota to patients with various nosological forms. To select healthy volunteers for autologous and heterologous transfusion of feces and a group of placebo-control. Create a bank of fecal samples of healthy donors; Conduct a procedure for fecal microbiota transplantation for a sample of patients and healthy volunteers; Analyze the efficacy of therapy with TFM on the sample of patients; Analyze the effect of autologous, heterologous TFM and placebo on healthy volunteers; 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

Official Title
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Study of the Effects of Fecal Microbiota Transplantation for Correction of the Physiological State of the Human Body in Norm and in Pathology

Conditions
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Ulcerative Colitis, Irritable Bowel Syndrome, Crohn Disease, Irritable Bowel

Intervention / Treatment
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* Other: Fecal Microbiota Transplantation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants with bowel diseases<br>Treatment by transplantation of fecal microbiota | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation<br>|
| Experimental: autologous transplantation of fecal microbiota - healthy<br>Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules) | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation<br>|
| Experimental: Both autologous and heterologous transplantation - healthy<br>Healthy volunteers will receive both autologous and heterologous transplantation (capsules) | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation<br>|
| Placebo Comparator: placebo capsules - healthy<br>Healthy volunteers will receive placebo capsules | Other: Fecal Microbiota Transplantation<br>* Fecal Microbiota Transplantation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ulcerative Colitis remission | Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3 | 1 month after transplantation. Change from Baseline - 1 day before transplantation | 
| Crohn Disease remission | Crohn Disease remission defined as a Harvey-bradshaw index <3. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Ulcerative Colitis symptoms. | Defined as improvement in SCCAI. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. | 
| Change in gut microbiome | Diversity and variability of gut microbiome. | 1 month after transplantation. Change from Baseline - 1 day before transplantation. |