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

Primary Purpose

Ulcerative Colitis, Irritable Bowel Syndrome, Crohn Disease

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Fecal Microbiota Transplantation
Sponsored by
Federal Research and Clinical Center of Physical-Chemical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • FRCC PCM

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Participants with bowel diseases

autologous transplantation of fecal microbiota - healthy

Both autologous and heterologous transplantation - healthy

placebo capsules - healthy

Arm Description

Treatment by transplantation of fecal microbiota

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

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

Healthy volunteers will receive placebo capsules

Outcomes

Primary Outcome Measures

Ulcerative Colitis remission
Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3
Crohn Disease remission
Crohn Disease remission defined as a Harvey-bradshaw index <3.

Secondary Outcome Measures

Improvement in Ulcerative Colitis symptoms.
Defined as improvement in SCCAI.
Change in gut microbiome
Diversity and variability of gut microbiome.

Full Information

First Posted
May 17, 2019
Last Updated
July 4, 2019
Sponsor
Federal Research and Clinical Center of Physical-Chemical Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04011943
Brief Title
Fecal Microbiota Transplantation for Health Improvement (TFM3)
Acronym
TFM3
Official Title
Study of the Effects of Fecal Microbiota Transplantation for Correction of the Physiological State of the Human Body in Norm and in Pathology
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
December 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research and Clinical Center of Physical-Chemical Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis, Irritable Bowel Syndrome, Crohn Disease, Irritable Bowel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Participant
Allocation
Non-Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Participants with bowel diseases
Arm Type
Experimental
Arm Description
Treatment by transplantation of fecal microbiota
Arm Title
autologous transplantation of fecal microbiota - healthy
Arm Type
Experimental
Arm Description
Healthy volunteers will receive autologous transplantation of fecal microbiota (capsules)
Arm Title
Both autologous and heterologous transplantation - healthy
Arm Type
Experimental
Arm Description
Healthy volunteers will receive both autologous and heterologous transplantation (capsules)
Arm Title
placebo capsules - healthy
Arm Type
Placebo Comparator
Arm Description
Healthy volunteers will receive placebo capsules
Intervention Type
Other
Intervention Name(s)
Fecal Microbiota Transplantation
Intervention Description
Fecal Microbiota Transplantation
Primary Outcome Measure Information:
Title
Ulcerative Colitis remission
Description
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
Title
Crohn Disease remission
Description
Crohn Disease remission defined as a Harvey-bradshaw index <3.
Time Frame
1 month after transplantation. Change from Baseline - 1 day before transplantation.
Secondary Outcome Measure Information:
Title
Improvement in Ulcerative Colitis symptoms.
Description
Defined as improvement in SCCAI.
Time Frame
1 month after transplantation. Change from Baseline - 1 day before transplantation.
Title
Change in gut microbiome
Description
Diversity and variability of gut microbiome.
Time Frame
1 month after transplantation. Change from Baseline - 1 day before transplantation.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Ilina, MD
Organizational Affiliation
FRCC PCM
Official's Role
Principal Investigator
Facility Information:
Facility Name
FRCC PCM
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No

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Fecal Microbiota Transplantation for Health Improvement (TFM3)

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