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

• Sponsor: Federal Research and Clinical Center of Physical-Chemical Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT04579263
• Collaborator: Endocrinology Research Centre, Moscow (Other)
• Enrollment: 2
• Locations: 2
• Arms: 2
• Actual Duration (Months): 7.2
• Patient Per Site: 1
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Obesity; Familial	Other: Fecal microbiota	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 2 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• 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 therapyTwo 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
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Feb 15, 2020
• Actual Primary Completion Date: Aug 15, 2020
• Actual Study Completion Date: Sep 22, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient with diabetes mellitus type 1 (T1DM) Treatment by transplantation of fecal microbiota	Other: Fecal microbiota; Transplantation of fecal microbiota of healthy donor with normal body mass index
Experimental: Patient with diabetes mellitus type 2 (T2DM) Treatment by transplantation of fecal microbiota	Other: Fecal microbiota; Transplantation of fecal microbiota of healthy donor with normal body mass index

Outcome Measures

Primary Outcome Measures

1. Change in insulin sensitivity within FMT, 6 months after FMT] [6 months after FMT]

   participants will undergo euglycaemic glucose clamp study

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 50 Years
• Sexes Eligible for Study: Male
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Endocrinology Research Centre, Moscow	Moscow		Russian Federation	117036
2	Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)	Moscow		Russian Federation	117312

Sponsors and Collaborators

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

Investigators

• Study Director: Elena Ilina, MD, Federal Research and Clinical Center of Physical-Chemical Medicine
• Study Director: Marina Shestakova, MD, Endocrinology Research Centre, Moscow
• Principal Investigator: 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Federal Research and Clinical Center of Physical-Chemical Medicine
• ClinicalTrials.gov Identifier: NCT04579263
• Other Study ID Numbers: FMT-D1D2
• First Posted: Oct 8, 2020
• Last Update Posted: Oct 8, 2020
• Last Verified: Sep 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Oct 8, 2020