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

NCT04579263 | Completed

• 1 other identifier: FMT-D1D2
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Obesity; Familial

Outcome Measures

Primary Outcomes (1)

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

  participants will undergo euglycaemic glucose clamp study

  6 months after FMT

Study Arms (2)

Patient with diabetes mellitus type 1 (T1DM)

EXPERIMENTAL

Treatment by transplantation of fecal microbiota

Other: Fecal microbiota

Patient with diabetes mellitus type 2 (T2DM)

EXPERIMENTAL

Treatment by transplantation of fecal microbiota

Other: Fecal microbiota

Interventions

Fecal microbiota OTHER

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

Patient with diabetes mellitus type 1 (T1DM); Patient with diabetes mellitus type 2 (T2DM)

Eligibility Criteria

• Age: 40 Years - 50 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Federal Research and Clinical Center of Physical-Chemical Medicine: lead
• Endocrinology Research Centre, Moscow: collaborator

Study Sites (2)

Endocrinology Research Centre, Moscow

Moscow, 117036, Russia

Location

Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)

Moscow, 117312, Russia

Location

MeSH Terms

Conditions

Obesity

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Elena Ilina, MD

  Federal Research and Clinical Center of Physical-Chemical Medicine

  STUDY DIRECTOR

• Marina Shestakova, MD

  Endocrinology Research Centre, Moscow

  STUDY DIRECTOR

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: September 22, 2020
• First Posted: October 8, 2020
• Study Start: February 15, 2020
• Primary Completion: August 15, 2020
• Study Completion: September 22, 2020
• Last Updated: October 8, 2020

Record last verified: 2020-09

Locations

RU (2)