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OpenTrials
Completed

NCT Number: NCT05076656

Epigenetic and Microbiota Modifications

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.

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Key information

Conditions

Diabetes type2 Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lactobacillus fermentum D3

Dietary Supplement

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

Other names: PCT/EP 2012058214

Fecal Microbiota Transplant (FMT)

Biological

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

Placebo

Drug

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

Primary outcomes

  1. Changes in HOMA-IR

    Time frame: Baseline, 12 weeks

    Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)

Secondary outcomes

  1. Changes in gut microbiota

    Time frame: Baseline, 12 weeks

    Change from baseline in 16S rRNA amplicons after 3 months

  2. Changes in glucose metabolism

    Time frame: Baseline, 12 weeks

    Change from baseline in oral glucose tolerance test (OGTT)

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Registry information

Official study title

Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

Acronym: EPI-MICROBIO

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Oct 13, 2021
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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