EPI-MICROBIO: Epigenetic and Microbiota Modifications

Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (Other)
Overall Status
Recruiting
CT.gov ID
NCT05076656
Collaborator
(none)
30
Enrollment
1
Location
3
Arms
36.7
Anticipated Duration (Months)
0.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or DiseaseIntervention/TreatmentPhase
  • Dietary Supplement: Lactobacillus fermentum D3
  • Biological: Fecal microbiota transplant (FMT)
  • Drug: Placebo
Early Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Basic Science
Official Title:
Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
Actual Study Start Date :
Jun 10, 2019
Anticipated Primary Completion Date :
Dec 31, 2021
Anticipated Study Completion Date :
Jun 30, 2022

Arms and Interventions

ArmIntervention/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

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. Changes in gut microbiota [Baseline, 12 weeks]

      Change from baseline in 16S rRNA amplicons after 3 months

    2. Changes in glucose metabolism [Baseline, 12 weeks]

      Change from baseline in oral glucose tolerance test (OGTT)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Hospital Universitario Virgen de la VictoriaMálagaSpain29010

    Sponsors and Collaborators

    • 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 (IBIMA).

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    ClinicalTrials.gov Identifier:
    NCT05076656
    Other Study ID Numbers:
    • EPIGEN-MICROBIOTA
    First Posted:
    Oct 13, 2021
    Last Update Posted:
    Oct 13, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 13, 2021