Epigenetic and Microbiota Modifications

Early Phase 1

Completed

• Conditions: Diabetes type2; Obesity
• Interventions: Dietary Supplement: Lactobacillus fermentum D3; Biological: Fecal microbiota transplant (FMT); Drug: Placebo

• Registration Number: NCT05076656
• Lead Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-06-10
• Primary Completion: 2020-10-17
• Status Verified: 2021-07
• Study First Submitted: 2021-09-15
• Study First Submitted QC: 2021-09-29
• Study First Posted: 2021-10-13
• Study Completion: 2022-06-30
• Last Update Submitted: 2022-07-21
• Last Update Posted: 2022-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotics arm	Lactobacillus fermentum D3	Individuals who receive a probiotics pill daily: Lactobacillus fermentum D3 (PCT/EP 2012058214)
FMT arm	Fecal microbiota transplant (FMT)	Individuals who receive a FMT in the form of pills with fecal material from a healthy donor.
Control arm	Placebo	Individuals who receive a probiotics pill daily of placebo (milk powder)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Changes in glucose metabolism	Baseline, 12 weeks	Change from baseline in oral glucose tolerance test (OGTT)
Changes in gut microbiota	Baseline, 12 weeks	Change from baseline in 16S rRNA amplicons after 3 months

Trial Locations

Locations (1)

Hospital Universitario Virgen de la Victoria; 🇪🇸 Málaga, Spain