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Probiotic spores in sugar may tame hidden inflammation in overweight adults

NCT ID NCT07806383

Disease control Sponsor: Federico II University Source: ClinicalTrials.gov ↗

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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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 08, 2026 · Last updated Sep 09, 2026 · Updated 1 time

Summary

Researchers are testing whether a daily sugar-based synbiotic containing inulin and Bacillus coagulans BC30 spores can lower low-grade inflammation and improve heart and gut health in overweight adults. Twenty healthy overweight participants will take the synbiotic or a control product for four weeks each, with a break in between. The study measures blood markers of inflammation, blood sugar, cholesterol, gut permeability, and digestive symptoms. The goal is to see if this simple supplement could reduce cardiometabolic risk without changing diet or lifestyle.

What this could mean

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

Active substance
A sugar-based synbiotic product containing inulin and Bacillus coagulans BC30 spores
What this could lead to
If it works, this synbiotic could offer a simple daily supplement to reduce low-grade inflammation and cardiometabolic risk in overweight adults.
What could go wrong
This is a small, early crossover study with only 20 participants, so results may not apply broadly. The product contains sugar, which could offset some benefits, and digestive side effects are possible.

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 20 people

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

Started

May 2026

Expected to finish

Mar 2027

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

20 to 70 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: * Body Mass Index (BMI): 25-29.9 kg/m2 Exclusion Criteria: * Diabetes * Cardiovascular events (myocardial infarction and/or stroke) within the previous 6 months * Renal impairment (serum creatinine \>1.5 mg/dL) or hepatic impairment (ALT and/or AST levels more than twice the upper limit of normal) * Anemia (hemoglobin \<12 g/dL) * Treatment with lipid-lowering or anti-inflammatory medications * Use of antibiotics, probiotics, or prebiotics within the previous 3 months * Regular use of dietary supplements * Any other acute or chronic clinical condition that could significantly affect the study results and/or make study participation a health risk

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Conditions

The condition(s) this trial relates to.

Overweight

As listed by the trial registrant

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

Overweight adults

How to take part

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • Federico II University

    Naples, 80131, Italy

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