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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
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

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University Piemonte Orientale
Coordinator of this site? Confirm its status
VercelliItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.