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Gut bacteria eyed as hidden link between obesity and chronic infections

NCT ID NCT05975541

Knowledge-focused Sponsor: Azienda Ospedaliero Universitaria Maggiore della Carita Source: ClinicalTrials.gov ↗

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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.
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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 Results may not be published yet.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)
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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
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First seen Sep 10, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

Researchers are studying whether the mix of bacteria in the gut helps explain why people with obesity and type 2 diabetes get chronic infections more often. The study follows 80 adults, some with ongoing infections and some without, for 12 months. Participants give blood, stool, and saliva samples and answer questionnaires, but receive no experimental treatment. The goal is to compare gut bacteria and immune signals between the two groups.

What this could mean

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

What this could lead to
If researchers link certain gut bacteria to chronic infections in people with obesity and type 2 diabetes, that could point toward new ways to predict or prevent those infections.
What could go wrong
This is an observational study of 80 people at one center, so it can show patterns but not prove cause and effect. Any links found may not apply to other groups or lead to a treatment.

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.

Participants

About 80 people

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

Started

Oct 2023

Expected to finish

May 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.

Who is studied

The population of interest for this study will be recruited by the endocrinology of the hospital "Maggiore della Carità" of Novara. The patients recruited will be equally divided into the two groups according to the presence or not of concurrent infections and will be adequately matched by age, sex, and characteristics in order to maintain a certain homogeneity of the study.

Ages

18 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: * age between 18-65 years * ability to understand the study protocol * obesity with BMI between 30-40 kg/m2 * affects by type II diabetes * presence/absence of chronic infections * the possibility of equality in the two groups (matched for sex, age, and therapies) Exclusion Criteria: * psychological conditions that reduced the ability the comprehension of the study protocol * subjects undergoing a diet-therapeutic regimen; * subjects with the possibility of developing diabetic foot in the successive months * patients with relapsing infections * pregnancy * bariatric surgery * oncological and hematological pathologies * Hypogonadism * severe immunodepression * vaccination in the last two weeks * Alcohol or drug abuse * antibiotic therapy

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Conditions

The condition(s) this trial relates to.

Chronic Disease Obesity obesity disorder Persistent Infection type 2 diabetes mellitus

As listed by the trial registrant

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

Chronic disease Gut microbiota Obesity TYPE2DIABETES

How to take part

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  1. The places running it

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  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

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Contacts and locations

Locations

  • Maggiore della Carità Hospital

    RECRUITING

    Novara, Novara, 28100, Italy

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