Fecal Microbiota Transplantation for Health Improvement (TFM3)

N/AUnknownNCT04011943

Federal Research and Clinical Center of Physical-Chemical Medicine50 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Ulcerative Colitis Irritable Bowel Syndrome Crohn Disease Irritable Bowel

Interventions

Fecal Microbiota TransplantationOTHER

Fecal Microbiota Transplantation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

FRCC PCM

Moscow, Russia

Outcomes

Primary Outcomes

Ulcerative Colitis remission

Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index \<3

Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation

Crohn Disease remission

Crohn Disease remission defined as a Harvey-bradshaw index \<3.

Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.

Secondary Outcomes

Improvement in Ulcerative Colitis symptoms.

Defined as improvement in SCCAI.

Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.

Change in gut microbiome

Diversity and variability of gut microbiome.

Time frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation.

Data from ClinicalTrials.gov

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