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Gut bacteria may be key to heart health, new study suggests

NCT ID NCT07530575

Disease control Sponsor: PINER Pastor Manfredi Winery Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a probiotic called Limosilactobacillus fermentum CRL 1446 can improve health in 80 adults with heart disease risk factors like obesity, high blood pressure, and high cholesterol. Participants take either the probiotic or a placebo daily, and researchers measure effects on blood sugar, body composition, inflammation, and stress. The goal is to see if this friendly bacterium can help prevent or manage chronic heart conditions.

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

80 people

The number who actually took part.

Started

Feb 2026

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

40 to 65 years

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: Volunteers with the following conditions may be eligible: 1. Blood glucose greater than 100 mg/dl or pharmacological treatment for high blood glucose levels; 2. HDL cholesterol \< 40 mg/dl in men or \< 50 mg/dl in women, or pharmacological treatment for low HDL cholesterol levels; 3. Blood triglycerides \> 150 mg/dl or pharmacological treatment for high triglyceride levels; 4. Waist circumference \> 102 cm for men or \> 88 cm for women; 5. Arterial pressure \> 130/85 mmHg; 6. Sedentarism; 7. Smoking habit. Exclusion Criteria: Patients with a history of digestive surgeries, inflammatory bowel disease, patients with gastroenteritis in the last 6 months, cancer patients, patients with rheumatic pathologies, patients with liver disorders, immunological disorders or deficiencies, steatorrhea, antibiotic use in the last 3 months, or anemia of any cause or pregnancy/expectation of becoming pregnant during the study. \-

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Conditions

The condition(s) this trial relates to.

diabetes mellitus Dysbiosis hypertensive disorder hypertriglyceridemia Obesity obesity disorder Overweight

As listed by the trial registrant

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

Cholesterol (total and HDL) Diabetes (DM) Disbiosis Hypertension (without type 2 diabetes mellitus) Obesity Overweight (bmi > 25) Sedentarity SMOKE Stress (psychology) Triglycerides high

Contacts and locations

Locations

  • Raul Francisco Pastor

    Buenos Aires, Buenos Aires City, 1408, Argentina

  • TIEMPO MEDICO Health Research Center

    Buenos Aires, 1440, Argentina

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