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Could a probiotic calm gut inflammation in overweight people?

NCT ID NCT07253155

Disease control Sponsor: University of Ulster 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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests a probiotic called Streptococcus thermophilus (FX856) in 100 overweight or obese adults. The goal is to see if it can reduce mild gut inflammation and improve digestive symptoms. Participants will take the probiotic or a placebo in a crossover design, and researchers will measure inflammation markers and symptom scores.

What this could mean

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

Active substance
Streptococcus thermophilus (FX856) probiotic
What this could lead to
If it works, this could point toward a simple probiotic supplement to reduce gut inflammation and improve digestive symptoms in people with overweight or obesity.
What could go wrong
This is a small early-stage trial with only 100 people, so results may not apply to everyone. The probiotic may not reduce inflammation or symptoms as hoped.

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 100 people

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

Started

Oct 2025

Expected to finish

Sep 2028

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

18 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: * Either a BMI 25+ kg/m2 and be aged 40+ years or have a BMI 30+ kg/m2 and aged 18+ years * Males and females (not currently pregnant/lactating) * Omnivorous diet (consuming plant \& animal based foods) * Not taking any medication affecting the gastro-intestinal tract * No chronic gastro-intestinal illness * Not using fibre supplements or any probiotic or prebiotic products, e.g., Fybogel, Actimel, kefir or kimchee for at least 6 weeks prior to study * Not consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%) Exclusion Criteria: * Not aged 40+ years (if have a BMI 25-29.9 kg/m2) * BMI\<30 kg/m2 (if aged 18-39 years) * Pregnant/lactating female * Vegan/vegetarian/high protein diet * Chronic gastro-intestinal illness * Taking medication affecting the gastro-intestinal tract * Taking fibre supplements or any probiotic or prebiotic products * Consuming 7+ units of alcohol per day (e.g. 3 medium glasses of wine \~12%)

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Conditions

The condition(s) this trial relates to.

gastroenteritis Obesity obesity disorder Overweight

As listed by the trial registrant

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

Gut inflammation Overweight and obese volunteers

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

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Ulster University, Human Intervention Studies Unit

    Coleraine, BT52 1SA, United Kingdom

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