Fecal Microbiota Transplantation for Health Improvement (TFM3) (TFM3)

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

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

Study Overview

• Status: Unknown
• Conditions: Irritable Bowel Syndrome; Crohn Disease; Ulcerative Colitis; Irritable Bowel
• Intervention / Treatment: Other: Fecal Microbiota Transplantation

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

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • FRCC PCM

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

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

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine
• Investigators: Principal Investigator: Elena Ilina, MD, FRCC PCM

Study record dates

Study Major Dates

• Study Start (Actual): May 21, 2018
• Primary Completion (Anticipated): December 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: May 17, 2019
• First Submitted That Met QC Criteria: July 4, 2019
• First Posted (Actual): July 9, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2019
• Last Update Submitted That Met QC Criteria: July 4, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Irritable Bowel Syndrome; Crohn Disease
• Other Study ID Numbers: TFM3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No