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

Obesity; Familial Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04579263
• Other study ID #: FMT-D1D2
• Status: Completed
• Phase: N/A
• Start date: February 15, 2020
• Est. completion date: September 22, 2020

Study information

• Verified date: September 2020
• Source: Federal Research and Clinical Center of Physical-Chemical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2
• Est. completion date: September 22, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity; Familial

Intervention

Other:
• Fecal microbiota
Transplantation of fecal microbiota of healthy donor with normal body mass index

Locations

Country	Name	City	State
Russian Federation	Endocrinology Research Centre, Moscow	Moscow
Russian Federation	Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)	Moscow

Sponsors (2)

Lead Sponsor	Collaborator
Federal Research and Clinical Center of Physical-Chemical Medicine	Endocrinology Research Centre, Moscow

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in insulin sensitivity within FMT, 6 months after FMT]	participants will undergo euglycaemic glucose clamp study	6 months after FMT