NCT05076656

Epigenetic and Microbiota Modifications

Epigenetic and Microbiota Modifications in the Genesis of Adipose Tissue Dysfunction

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes type2
• Obesity

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-06-10
• Primary completion: 2020-10-17
• Completion: 2022-06-30
• First posted: 2021-10-13
• Last updated: 2022-07-22

Locations

1 site across 1 country: Spain