Status:
COMPLETED
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
Lead Sponsor:
Caelus Pharmaceuticals BV
Conditions:
PreDiabetes
Eligibility:
All Genders
18-65 years
Phase:
NA
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 pr...
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 intera...
Eligibility Criteria
Inclusion
- increased BMI \> 25,
- Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%
Exclusion
- Type 2 diabetes
Key Trial Info
Start Date :
January 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 10 2023
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT04495972
Start Date
January 15 2021
End Date
November 10 2023
Last Update
November 13 2023
Active Locations (1)
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1
University Piemonte Orientale
Vercelli, Italy