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Epigenetic and Microbiota Modifications (EPI-MICROBIO)

Primary Purpose

Diabetes type2, Obesity

Status
Completed
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Lactobacillus fermentum D3
Fecal microbiota transplant (FMT)
Placebo
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Diabetes type2 focused on measuring Diabetes type2, FMT, Probiotics, Microbiota

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hospital Universitario Virgen de la Victoria

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Probiotics arm

FMT arm

Control arm

Arm Description

Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)

Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.

Individuals who receive a probiotics pill daily of placebo (milk powder)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Changes in gut microbiota
Change from baseline in 16S rRNA amplicons after 3 months
Changes in glucose metabolism
Change from baseline in oral glucose tolerance test (OGTT)

Full Information

First Posted
September 15, 2021
Last Updated
July 21, 2022
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT05076656
Brief Title
Epigenetic and Microbiota Modifications
Acronym
EPI-MICROBIO
Official Title
Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
October 17, 2020 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes type2, Obesity
Keywords
Diabetes type2, FMT, Probiotics, Microbiota

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics arm
Arm Type
Experimental
Arm Description
Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
Arm Title
FMT arm
Arm Type
Experimental
Arm Description
Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
Arm Title
Control arm
Arm Type
Placebo Comparator
Arm Description
Individuals who receive a probiotics pill daily of placebo (milk powder)
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus fermentum D3
Other Intervention Name(s)
PCT/EP 2012058214
Intervention Description
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Intervention Type
Biological
Intervention Name(s)
Fecal microbiota transplant (FMT)
Intervention Description
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo in a white, gelatin capsule (orally), with powder milk
Primary Outcome Measure Information:
Title
Changes in HOMA-IR
Description
Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5)
Time Frame
Baseline, 12 weeks
Secondary Outcome Measure Information:
Title
Changes in gut microbiota
Description
Change from baseline in 16S rRNA amplicons after 3 months
Time Frame
Baseline, 12 weeks
Title
Changes in glucose metabolism
Description
Change from baseline in oral glucose tolerance test (OGTT)
Time Frame
Baseline, 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francisco J Tinahones, MD, PhD
Organizational Affiliation
Instituto de Investigacion Biomedica de Malaga
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Universitario Virgen de la Victoria
City
Málaga
ZIP/Postal Code
29010
Country
Spain

12. IPD Sharing Statement

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Epigenetic and Microbiota Modifications

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