Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
EARLY_PHASE1
22 participants
INTERVENTIONAL
2019-06-10
2022-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
SINGLE
Study Groups
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Probiotics arm
Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
Lactobacillus fermentum D3
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
FMT arm
Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
Fecal microbiota transplant (FMT)
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Control arm
Individuals who receive a probiotics pill daily of placebo (milk powder)
Placebo
Placebo in a white, gelatin capsule (orally), with powder milk
Interventions
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Lactobacillus fermentum D3
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Fecal microbiota transplant (FMT)
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Placebo
Placebo in a white, gelatin capsule (orally), with powder milk
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 30 kg/m2≤IMC≤40 kg/m2
* 30-70 years old
* HOMA-IR \>6
* Informed consent
Exclusion Criteria
* Diabetes medication different from metformin.
* History of cholecystectomy.
* Use of Probiotics, and/or antibiotics in the last 3 months
30 Years
70 Years
ALL
No
Sponsors
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Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
OTHER
Responsible Party
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Principal Investigators
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Francisco J Tinahones, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Instituto de Investigacion Biomedica de Malaga
Locations
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Hospital Universitario Virgen de la Victoria
Málaga, , Spain
Countries
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Other Identifiers
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EPIGEN-MICROBIOTA
Identifier Type: -
Identifier Source: org_study_id
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