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Can a daily probiotic capsule help older adults manage prediabetes?

NCT ID NCT07817290

Disease control Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 14, 2026 · Last updated Sep 15, 2026 · Updated 1 time

Summary

Researchers are testing whether a daily probiotic supplement can improve blood sugar, blood pressure, and body composition in people over 65 who have prediabetes or type 2 diabetes and known heart disease. Participants take one probiotic capsule each morning for 60 days, while a comparison group takes a placebo. The study measures blood sugar over time, blood pressure, weight, and other health markers before and after the supplement to see if the probiotic makes a difference.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a probiotic dietary supplement
What this could lead to
If the probiotic helps, it could offer a low-cost, easy way for older adults with prediabetes to support their blood sugar and heart health.
What could go wrong
This is a very small, early study of 15 people, so any changes may be due to chance or not apply to others. Probiotics can cause mild stomach upset in some people.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Nov 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

65 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients of either gender, over 65 years of age, able to understand the protocol procedures. * Known cardiovascular disease * Prediabetes or type 2 diabetes mellitus with HbA1c \< 7.0% on diet alone or metformin. Exclusion Criteria: * Age under 65 * Previous diagnosis of type 2 diabetes mellitus already undergoing drug therapy (except metformin) * Contraindications such as allergy to product components * Obesity secondary to diseases: genetic (Prader-Willi syndrome, Down syndrome); metabolic and endocrine (Cushing's syndrome, hypothyroidism) * Endocrine or liver disease or clinical evidence of chronic disease or gastrointestinal disorders or malabsorption disorders * History of adrenal adenoma or secondary arterial hypertension due to renal/adrenal causes * Arterial hypertension treated with an ACE inhibitor or ARB * Previous bariatric surgery

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder prediabetes syndrome type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prediabetes

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • SCDU Endocrinology. AOU Ospedale Maggiore della Carità

    RECRUITING

    Novara, 28100, Italy

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