Epigenetic and Microbiota Modifications

Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05076656

Acronym

EPI-MICROBIO

Enrollment

Registered

2021-10-13

Start date

2019-06-10

Completion date

2022-06-30

Last updated

2022-07-22

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

Conditions

Diabetes type2, Obesity

Keywords

Diabetes type2, FMT, Probiotics, Microbiota

Brief summary

In order to investigate how gut microbiota interventions are able to change gut microbiota population and impact insulin resistance, 30 type2 diabetes volunteers with obesity will be randomized to one of the three treatment groups: 1) probiotics arm, who will take a Lactobacillus fermentum D3 in pills daily; 2) FMT arm, who will take a lyophilized fecal microbiota transplant in pills; and 3) control group, who will take placebo pills. After 3 months, insulin resistance, glucose metabolism parameters, and gut microbiota variation will be assessed.

Interventions

DIETARY_SUPPLEMENTLactobacillus fermentum D3

Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.

BIOLOGICALFecal microbiota transplant (FMT)

Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.

DRUGPlacebo

Placebo in a white, gelatin capsule (orally), with powder milk

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

30 Years to 70 Years

Healthy volunteers

Inclusion criteria

* Type2 diabetes in treatment with metformin * 30 kg/m2≤IMC≤40 kg/m2 * 30-70 years old * HOMA-IR \>6 * Informed consent

Exclusion criteria

* psychopathologic alterations that do not permit the adherence to the trial. * Diabetes medication different from metformin. * History of cholecystectomy. * Use of Probiotics, and/or antibiotics in the last 3 months

Design outcomes

Primary

Measure	Time frame	Description
Changes in HOMA-IR	Baseline, 12 weeks	Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)

Secondary

Measure	Time frame	Description
Changes in gut microbiota	Baseline, 12 weeks	Change from baseline in 16S rRNA amplicons after 3 months
Changes in glucose metabolism	Baseline, 12 weeks	Change from baseline in oral glucose tolerance test (OGTT)

Countries

Spain

Outcome results

None listed

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