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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05076656
Other study ID # EPIGEN-MICROBIOTA
Secondary ID
Status Completed
Phase Early Phase 1
First received
Last updated
Start date June 10, 2019
Est. completion date June 30, 2022

Study information

Verified date July 2021
Source Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 22
Est. completion date June 30, 2022
Est. primary completion date October 17, 2020
Accepts healthy volunteers No
Gender All
Age group 30 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Lactobacillus fermentum D3
Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.
Biological:
Fecal microbiota transplant (FMT)
Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.
Drug:
Placebo
Placebo in a white, gelatin capsule (orally), with powder milk

Locations

Country Name City State
Spain Hospital Universitario Virgen de la Victoria Málaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in HOMA-IR Homeostasis Model Assessment of fasting Insulin Resistance (HOMA-IR: glucose (mmol/l( x insulin (pmol/l)/22.5) Baseline, 12 weeks
Secondary Changes in gut microbiota Change from baseline in 16S rRNA amplicons after 3 months Baseline, 12 weeks
Secondary Changes in glucose metabolism Change from baseline in oral glucose tolerance test (OGTT) Baseline, 12 weeks
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