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

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

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Key information

Conditions

Obesity; Familial Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

40 year–50 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Endocrinology Research Centre, Moscow, Moscow, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fecal microbiota

Other

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

Primary outcomes

Change in insulin sensitivity within FMT, 6 months after FMT]

Time frame: 6 months after FMT

participants will undergo euglycaemic glucose clamp study

Sponsors and collaborators

Lead sponsor

Federal Research and Clinical Center of Physical-Chemical Medicine

Other

Collaborators

Endocrinology Research Centre, Moscow

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2020
Study completion: 2020
First posted: Oct 8, 2020
Registry last updated: Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed