Epigenetic and Microbiota Modifications (EPI-MICROBIO)

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

Status and phase: Completed; Early Phase 1

Conditions: Obesity; Diabetes type2

Treatments: Drug: Placebo; Biological: Fecal microbiota transplant (FMT); Dietary Supplement: Lactobacillus fermentum D3

Study type: Interventional

Funder types: Other

Identifiers

NCT05076656

EPIGEN-MICROBIOTA

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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22 participants in 3 patient groups, including a placebo group

Probiotics arm

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus fermentum D3

FMT arm

Experimental group

Description:

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

Treatment:

Biological: Fecal microbiota transplant (FMT)

Control arm

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo