Intestinimonas for Prevention of Type 2 Diabetes Mellitus

PreDiabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495972
• Other study ID #: DM Prevent POC
• Status: Completed
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: November 10, 2023

Study information

• Verified date: November 2023
• Source: Caelus Pharmaceuticals BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: November 10, 2023
• Est. primary completion date: September 12, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• PreDiabetes

Intervention

Dietary Supplement:
• Intestinimonas-capsules
Capsules containing microbiota (Intestinimonas)
• Placebo-capsules
Placebo capsules are identical to the active treatment

Locations

Country	Name	City	State
Italy	University Piemonte Orientale	Vercelli

Sponsors (1)

Lead Sponsor	Collaborator
Caelus Pharmaceuticals BV

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity	as measured by Homeostatic Model Assessment (HOMA) - index	12 weeks
Secondary	Concentration of Fasting glucose	as measured by Glucose in plasma	12 weeks
Secondary	Level of 2-hour blood glucose Area Under the Curve (AUC)	as measured by standard Oral Glucose Tolerance Test (OGTT)	12 weeks