Obesity; FamilialNCT04579263

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

A study testing Fecal microbiota in people with Obesity; Familial, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 2 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Search for mechanisms of the effect of fecal microbiota transplantation on patients with obesity Read more about this study

Who is it for?: Ages 40 to 50 years, men onlyHealthy volunteers can take part
Conditions the study is for: Obesity; Familial
What is being tested?: Fecal microbiota
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 2 sitesRussia
Study dates: 15 Feb 2020to 22 Sep 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 50 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Russia2 sites

Endocrinology Research Centre, Moscow
Moscow, 117036
Federal Research and Clinical Center of Physical-Chemical Medicine, Moscow (FRCC PCM)
Moscow, 117312

Other trials in Russia

About this study

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

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

Read the detailed description

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.

Conditions: Obesity; Familial
Being tested: Fecal microbiota
Medical subject headings: Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04579263
Study group	Role	What they receive
Patient with diabetes mellitus type 1 (T1DM)	Experimental	Treatment by transplantation of fecal microbiota Receives: Other: Fecal microbiota
Patient with diabetes mellitus type 2 (T2DM)	Experimental	Treatment by transplantation of fecal microbiota Receives: Other: Fecal microbiota

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in insulin sensitivity within FMT, 6 months after FMT]
participants will undergo euglycaemic glucose clamp study
Measured: 6 months after FMT

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Feb 202022 Sep 2020

First posted8 Oct 2020
Study start15 Feb 2020
Primary completion15 Aug 2020
Study completion22 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Obesity; FamilialStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
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
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04579263
Sponsor's protocol ID: FMT-D1D2
Status last verified: Sep 2020
First submitted: 22 Sep 2020
Last updated: 8 Oct 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Family Functioning in Obesity Treatment for Mexican Americans
Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
RecruitingPhase 4
FutureShape Family
Obesity, Overweight
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky

All Obesity; Familial trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04579263
Acronym / sponsor ID: FMT-D1D2
Conditions: Obesity; Familial
Study type: Interventional
Recruitment status: Completed
Enrolment: 2 participants (actual)
Lead sponsor: Federal Research and Clinical Center of Physical-Chemical MedicineUniversity, hospital or other
Collaborators: Endocrinology Research Centre, Moscow
Study start: 15 Feb 2020 (actual)
Primary completion: 15 Aug 2020 (actual)
Study completion: 22 Sep 2020 (actual)
First posted: 8 Oct 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
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

Arm	Type	Receives
Patient with diabetes mellitus type 1 (T1DM)	Experimental	Other: Fecal microbiotaTreatment by transplantation of fecal microbiota
Patient with diabetes mellitus type 2 (T2DM)	Experimental	Other: Fecal microbiotaTreatment by transplantation of fecal microbiota

Who may qualify

Ages: 40 to 50 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Fecal microbiotaTransplantation of fecal microbiota of healthy donor with normal body mass index	Other	Patient with diabetes mellitus type 1 (T1DM), Patient with diabetes mellitus type 2 (T2DM)

Primary outcome

Change in insulin sensitivity within FMT, 6 months after FMT]
Time frame: 6 months after FMT
participants will undergo euglycaemic glucose clamp study

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2020.

Related trials for Obesity; Familial

Active, not recruiting
Family Functioning in Obesity Treatment for Mexican Americans
Obesity
Enrolling by invitation
Impact of a Playful Family Education Strategy With ICT on Childhood Obesity Prevention
Pediatric Obesity, Childhood Obesity
RecruitingPhase 4
FutureShape Family
Obesity, Overweight
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
Growing Healthy Children and Families in Rural Arkansas
Pediatric Obesity, Health Behavior, Risky

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Elena Ilina, MD study director

Federal Research and Clinical Center of Physical-Chemical Medicine

Marina Shestakova, MD study director

Endocrinology Research Centre, Moscow

Elena Zhgun, PhD principal investigator

Federal Research and Clinical Center of Physical-Chemical Medicine

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Fecal microbiota in people with Obesity; Familial, run by Federal Research and Clinical Center of Physical-Chemical Medicine at 2 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in insulin sensitivity within FMT, 6 months after FMT] (time frame: 6 months after FMT). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04579263.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2020.