PreDiabetesNCT04495972
Intestinimonas for Prevention of Type 2 Diabetes Mellitus
A study testing Intestinimonas-capsules in people with PreDiabetes, run by Caelus Pharmaceuticals BV at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Intestinimonas-capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteItaly
- Study dates
- 15 Jan 2021to 10 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- increased BMI > 25,
- Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose > 140 after OGTT, or HbA1c 5.7% - 6.4%
Who cannot join
- Type 2 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
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.
Read the 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).
- Conditions
- PreDiabetes
- Being tested
- Intestinimonas-capsules, Placebo-capsules
- Keywords
- Prediabetic State, Metabolic Syndrome
- Medical subject headings
- Prediabetic State, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinimonas-capsulesDietary supplement
Capsules containing microbiota (Intestinimonas)
Placebo-capsulesDietary supplement
Placebo capsules are identical to the active treatment
| Study group | Role | What they receive |
|---|---|---|
| Experimental arm: Intestinimonas | Active comparator | Intestinimonas in capsules Receives: Dietary Supplement: Intestinimonas-capsules |
| Placebo arm: Placebo | Placebo comparator | Placebo in capsules Receives: Dietary Supplement: Placebo-capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insulin sensitivity
as measured by Homeostatic Model Assessment (HOMA) - index
Measured: 12 weeks
Secondary outcomes (2)
Concentration of Fasting glucose
as measured by Glucose in plasma
Measured: 12 weeks
Level of 2-hour blood glucose Area Under the Curve (AUC)
as measured by standard Oral Glucose Tolerance Test (OGTT)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start15 Jan 2021
- Primary completion12 Sep 2023
- Study completion10 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Double-blind, randomized, placebo-controlled study
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Caelus Pharmaceuticals BV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495972
- Sponsor's protocol ID
- DM Prevent POC
- Status last verified
- Nov 2023
- First submitted
- 27 Jul 2020
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Intestinal Microbiota-based Product for Preventing Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04495972
- Acronym / sponsor ID
- DM Prevent POC
- Conditions
- PreDiabetes
- Keywords
- Prediabetic State, Metabolic Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Caelus Pharmaceuticals BVIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 10 Nov 2023 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind, randomized, placebo-controlled study
| Arm | Type | Receives |
|---|---|---|
| Experimental arm: Intestinimonas | Active comparator | Dietary Supplement: Intestinimonas-capsulesIntestinimonas in capsules |
| Placebo arm: Placebo | Placebo comparator | Dietary Supplement: Placebo-capsulesPlacebo in capsules |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- increased BMI > 25,
- Fasting Plasma Glucose (FPG) 100-125 mg/dl or glucose > 140 after OGTT, or HbA1c 5.7% - 6.4%
Key exclusion criteria (1 listed)
- Type 2 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intestinimonas-capsulesCapsules containing microbiota (Intestinimonas) | Dietary supplement | Experimental arm: Intestinimonas |
| Placebo-capsulesPlacebo capsules are identical to the active treatment | Dietary supplement | Placebo arm: Placebo |
Primary outcome
Insulin sensitivity
Time frame: 12 weeks
as measured by Homeostatic Model Assessment (HOMA) - index
2 secondary outcomes
Concentration of Fasting glucose
Time frame: 12 weeks
Level of 2-hour blood glucose Area Under the Curve (AUC)
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intestinimonas-capsules in people with PreDiabetes, run by Caelus Pharmaceuticals BV at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin sensitivity (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2023.