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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-15

Study Completion Date

2020-09-22

Brief Summary

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

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Detailed Description

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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.

Conditions

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Obesity; Familial

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Two obese patients selected according to the inclusion criteria will undergo fecal microbiota transplantation from a healthy donor with a normal body mass index against the background of glucose-lowering therapy

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patient with diabetes mellitus type 1 (T1DM)

Treatment by transplantation of fecal microbiota

Group Type EXPERIMENTAL

Fecal microbiota

Intervention Type OTHER

Transplantation of fecal microbiota of healthy donor with normal body mass index

Patient with diabetes mellitus type 2 (T2DM)

Treatment by transplantation of fecal microbiota

Group Type EXPERIMENTAL

Fecal microbiota

Intervention Type OTHER

Transplantation of fecal microbiota of healthy donor with normal body mass index

Interventions

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Fecal microbiota

Transplantation of fecal microbiota of healthy donor with normal body mass index

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes