NCT04495972Completed
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov · Last updated 13 Nov 2023
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 26 (actual)
- First submitted
- 27 Jul 2020
- Start date
- 15 Jan 2021
- Primary completion date
- 12 Sept 2023
- Lead sponsor
- Caelus Pharmaceuticals BV
- Diseases
- Type 2 diabetes
- NCT number
- NCT04495972
What you commit to
- Study type: Interventional
- Participants enrolled: 26
- From 15 Jan 2021 to the primary completion date, 12 Sept 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Type 2 diabetes
Who the study is looking for
- increased BMI \> 25,
- Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose \> 140 after OGTT, or HbA1c 5.7% - 6.4%
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Piemonte Orientale Coordinator of this site? Confirm its status | Vercelli | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.