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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04579263
Enrollment
2
Registered
2020-10-08
Start date
2020-02-15
Completion date
2020-09-22
Last updated
2020-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity; Familial

Brief summary

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

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.

Interventions

OTHERFecal microbiota

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

Sponsors

Endocrinology Research Centre, Moscow
CollaboratorOTHER_GOV
Federal Research and Clinical Center of Physical-Chemical Medicine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
MALE
Age
40 Years to 50 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in insulin sensitivity within FMT, 6 months after FMT]6 months after FMTparticipants will undergo euglycaemic glucose clamp study

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026