Epigenetic and Microbiota Modifications

NCT05076656 | Completed Early Phase 1

• 1 other identifier: EPIGEN-MICROBIOTA
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes type2; Obesity

Keywords

Diabetes type2; FMT; Probiotics; Microbiota

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Changes in gut microbiota

  Baseline, 12 weeks

• Changes in glucose metabolism

  Baseline, 12 weeks

Study Arms (3)

Probiotics arm

EXPERIMENTAL

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

Dietary Supplement: Lactobacillus fermentum D3

FMT arm

EXPERIMENTAL

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

Biological: Fecal microbiota transplant (FMT)

Control arm

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Lactobacillus fermentum D3 DIETARY_SUPPLEMENT

Lactobacillus fermentum D3 in a white, gelatin capsule (orally), with lyophilized L. fermentum D3 without preservatives, sugars, or additives.

Also known as: PCT/EP 2012058214

Probiotics arm

Fecal microbiota transplant (FMT) BIOLOGICAL

Fecal microbiota transplant (FMT) in a green, gelatin capsule (orally), with lyophilized fecal material.

FMT arm

Placebo DRUG

Placebo in a white, gelatin capsule (orally), with powder milk

Control arm

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type2 diabetes in treatment with metformin
• kg/m2≤IMC≤40 kg/m2
• years old
• HOMA-IR \>6
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Hospital Universitario Virgen de la Victoria

Málaga, 29010, Spain

Location

MeSH Terms

Conditions

Obesity

Interventions

Fecal Microbiota Transplantation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics

Study Officials

• Francisco J Tinahones, MD, PhD

  Instituto de Investigacion Biomedica de Malaga

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2021
• First Posted: October 13, 2021
• Study Start: June 10, 2019
• Primary Completion: October 17, 2020
• Study Completion: June 30, 2022
• Last Updated: July 22, 2022

Record last verified: 2021-07

Locations

ES (1)