Fecal Microbiota Transplantation for Health Improvement (TFM3)

NCT ID: NCT04011943

Last Updated: 2019-07-09

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2020-12-01

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

Conditions

Ulcerative Colitis; Irritable Bowel Syndrome; Crohn Disease; Irritable Bowel

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Participants with bowel diseases

Treatment by transplantation of fecal microbiota

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: OTHER

Fecal Microbiota Transplantation

autologous transplantation of fecal microbiota - healthy

Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: OTHER

Fecal Microbiota Transplantation

Both autologous and heterologous transplantation - healthy

Healthy volunteers will receive both autologous and heterologous transplantation (capsules)

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: OTHER

Fecal Microbiota Transplantation

placebo capsules - healthy

Healthy volunteers will receive placebo capsules

Group Type: PLACEBO_COMPARATOR

Fecal Microbiota Transplantation

Intervention Type: OTHER

Fecal Microbiota Transplantation

Interventions

Fecal Microbiota Transplantation

Fecal Microbiota Transplantation

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal Research and Clinical Center of Physical-Chemical Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elena Ilina, MD

Role: PRINCIPAL_INVESTIGATOR

FRCC PCM

Locations

FRCC PCM

Moscow, , Russia

Countries

Russia

Other Identifiers

TFM3

Identifier Type: -

Identifier Source: org_study_id