Assessment of the Health Improvement of Obese Patients After Fecal Microbiota Transplantation (FMT)

October 7, 2020 updated by: Federal Research and Clinical Center of Physical-Chemical Medicine

Assessment of Improvement in Glycemic Control, Weight, and Insulin Sensitivity in Obese Patients After Fecal Microbiota Transplantation (FMT) Against the Background of Glucose-lowering Therapy

Search for mechanisms of the effect of fecal microbiota transplantation on patients with obesity

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

  1. To select recipients of fecal samples according to eligibility criteria;
  2. To perform fecal microbiota transplantation for patients with obesity;
  3. To analyze the efficacy of fecal microbiota transplantation for patients with obesity within six months after therapy.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Moscow, Russian Federation, 117312
        • Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)
      • Moscow, Russian Federation, 117036
        • Endocrinology Research Centre, Moscow

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • age of patients - from 18 to 75 years, both sexes;
  • patients with obesity (body mass index ≥40
  • patient's informed consent to perform fecal microbiota transplantation

Exclusion Criteria:

  • presence of a concomitant chronic infectious disease or malignancy
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with diabetes mellitus type 1 (T1DM)
Treatment by transplantation of fecal microbiota
Other: Fecal microbiota
Transplantation of fecal microbiota of healthy donor with normal body mass index
Experimental: Patient with diabetes mellitus type 2 (T2DM)
Treatment by transplantation of fecal microbiota
Other: Fecal microbiota
Transplantation of fecal microbiota of healthy donor with normal body mass index

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in insulin sensitivity within FMT, 6 months after FMT]
Time Frame: 6 months after FMT
participants will undergo euglycaemic glucose clamp study
6 months after FMT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal Research and Clinical Center of Physical-Chemical Medicine

Collaborators

Endocrinology Research Centre, Moscow

Investigators

  • Study Director: Elena Ilina, MD, Federal Research and Clinical Center of Physical-Chemical Medicine
  • Study Director: Marina Shestakova, MD, Endocrinology Research Centre, Moscow
  • Principal Investigator: Elena Zhgun, PhD, Federal Research and Clinical Center of Physical-Chemical Medicine
  • Principal Investigator: Elena Pokrovskaya, Endocrinology Research Centre, Moscow
  • Principal Investigator: Igor Sklyanik, Endocrinology Research Centre, Moscow

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2020

Primary Completion (Actual)

August 15, 2020

Study Completion (Actual)

September 22, 2020

Study Registration Dates

First Submitted

September 22, 2020

First Submitted That Met QC Criteria

October 7, 2020

First Posted (Actual)

October 8, 2020

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 7, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FMT-D1D2

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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