Intestinimonas for Prevention of Type 2 Diabetes Mellitus

Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04495972

Enrollment

Registered

2020-08-03

Start date

2021-01-15

Completion date

2023-11-10

Last updated

2023-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PreDiabetes

Keywords

Prediabetic State, Metabolic Syndrome

Brief 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.

Detailed description

The study aims to assess the effects of a microbiota-based product containing Intestinimonas in adults with pre-diabetes. Intestinimonas is an aerobic microorganism which produces butyrate and interacts with the local microbiota in small and large intestine. In preclinical studies, it was demonstrated that the insulin sensitivity can be enhanced by Intestinimonas and similar microbiota. The purpose is to determine the safety and efficacy of the microbiota-based product on insulin sensitivity in a target group of prediabetic individuals. The study participants will be subjects who are overweight and are at risk of developing Type 2 diabetes. The key objective of this randomized, placebo-controlled study is to evaluate whether Intestinimonas is able to improve the insulin sensitivity, to assess the response to the oral glucose tolerance test (OGTT) and whether it is able to modulate the microbiota composition in the study subjects. Furthermore, in a open-label follow-up of 14 weeks the effect of a high-dose of Intestinimonas will be compared with the low-dose tested in the initial double-blind Randomised Controlled Trial (RCT).

Interventions

DIETARY_SUPPLEMENTIntestinimonas-capsules

Capsules containing microbiota (Intestinimonas)

DIETARY_SUPPLEMENTPlacebo-capsules

Placebo capsules are identical to the active treatment

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

Double-blind, randomized, placebo-controlled study

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* increased BMI \> 25, * Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%

Exclusion criteria

* Type 2 diabetes

Design outcomes

Primary

Measure	Time frame	Description
Insulin sensitivity	12 weeks	as measured by Homeostatic Model Assessment (HOMA) - index

Secondary

Measure	Time frame	Description
Concentration of Fasting glucose	12 weeks	as measured by Glucose in plasma
Level of 2-hour blood glucose Area Under the Curve (AUC)	12 weeks	as measured by standard Oral Glucose Tolerance Test (OGTT)

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026