EPI-MICROBIO: Epigenetic and Microbiota Modifications
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 Disease | Intervention/Treatment | Phase |
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Early Phase 1 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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:
|
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
- 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
- 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)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Type2 diabetes in treatment with metformin
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30 kg/m2≤IMC≤40 kg/m2
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30-70 years old
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HOMA-IR >6
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Informed consent
Exclusion Criteria:
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psychopathologic alterations that do not permit the adherence to the trial.
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Diabetes medication different from metformin.
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History of cholecystectomy.
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Use of Probiotics, and/or antibiotics in the last 3 months
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Hospital Universitario Virgen de la Victoria | Málaga | Spain | 29010 |
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.- EPIGEN-MICROBIOTA