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Intestinimonas for Prevention of Type 2 Diabetes Mellitus

NCT04495972 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2023-11-13

No results posted yet for this study

Summary

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. In particular, the objective is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects.

Conditions

Interventions

DIETARY_SUPPLEMENT

Intestinimonas-capsules

Capsules containing microbiota (Intestinimonas)

DIETARY_SUPPLEMENT

Placebo-capsules

Placebo capsules are identical to the active treatment

Sponsors & Collaborators

  • Caelus Pharmaceuticals BV

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
FACTORIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-15
Primary Completion
2023-09-12
Completion
2023-11-10

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04495972 on ClinicalTrials.gov