Epigenetic and Microbiota Modifications (EPI-MICROBIO)

July 21, 2022 updated by: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotics arm
Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
Dietary supplement: Lactobacillus fermentum D3
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Other Names:
  • PCT/EP 2012058214
Experimental: FMT arm
Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
Biological: Fecal microbiota transplant (FMT)
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Placebo Comparator: Control arm
Individuals who receive a probiotics pill daily of placebo (milk powder)
Drug: Placebo
Placebo in a white, gelatin capsule (orally), with powder milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

  • Principal Investigator: Francisco J Tinahones, MD, PhD, Instituto de Investigación Biomédica de Málaga

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2019

Primary Completion (Actual)

October 17, 2020

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

September 15, 2021

First Submitted That Met QC Criteria

September 29, 2021

First Posted (Actual)

October 13, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2022

Last Update Submitted That Met QC Criteria

July 21, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIGEN-MICROBIOTA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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