Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04011943
Recruitment Status : Enrolling by invitation
First Posted : July 9, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Federal Research and Clinical Center of Physical-Chemical Medicine

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

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Irritable Bowel Syndrome Crohn Disease Irritable Bowel Other: Fecal Microbiota Transplantation Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant)
Primary Purpose: Treatment
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
Actual Study Start Date : May 21, 2018
Estimated Primary Completion Date : December 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Ulcerative Colitis remission [ Time Frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation ]
    Ulcerative Colitis remission defined as a Simple Clinical Colitis Activity Index <3

  2. Crohn Disease remission [ Time Frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation. ]
    Crohn Disease remission defined as a Harvey-bradshaw index <3.


Secondary Outcome Measures :
  1. Improvement in Ulcerative Colitis symptoms. [ Time Frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation. ]
    Defined as improvement in SCCAI.

  2. Change in gut microbiome [ Time Frame: 1 month after transplantation. Change from Baseline - 1 day before transplantation. ]
    Diversity and variability of gut microbiome.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011943


Locations
Layout table for location information
Russian Federation
FRCC PCM
Moscow, Russian Federation
Sponsors and Collaborators
Federal Research and Clinical Center of Physical-Chemical Medicine
Investigators
Layout table for investigator information
Principal Investigator: Elena Ilina, MD FRCC PCM
Layout table for additonal information
Responsible Party: Federal Research and Clinical Center of Physical-Chemical Medicine
ClinicalTrials.gov Identifier: NCT04011943    
Other Study ID Numbers: TFM3
First Posted: July 9, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Crohn Disease
Colitis, Ulcerative
Irritable Bowel Syndrome
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Colitis
Colonic Diseases
Colonic Diseases, Functional