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Gut InflammationNCT07253155

Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.

A study testing Probiotic Arm in people with Gut Inflammation and Overweight and Obese Volunteers, run by University of Ulster at 1 site in United Kingdom.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Inflammatory bowel disease (IBD) affects over 6.8 million people worldwide, with current treatments often causing side effects and poor patient compliance. Dysbiosis of gut microbiota is a key factor, and while probiotics are considered safe and beneficial, conventional strains fail to function effectively during… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Probiotic Arm
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
1 siteUnited Kingdom
Study dates
14 Oct 2025to 1 Sep 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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%)

Who cannot join

  • 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%)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United Kingdom1 site
  • Ulster University, Human Intervention Studies Unit

    Coleraine, BT52 1SA

Other trials in United Kingdom

About this study

Inflammatory bowel disease (IBD) affects over 6.8 million people worldwide, with current treatments often causing side effects and poor patient compliance. Dysbiosis of gut microbiota is a key factor, and while probiotics are considered safe and beneficial, conventional strains fail to function effectively during active inflammation due to high iron levels in the gut. Streptococcus thermophilus (FX856), unlike traditional probiotics, can thrive in this iron-rich environment, promoting mucosal healing. A 2-way crossover intervention study will be conducted with FX856 supplementation in overweight and obese individuals who often exhibit mild gut inflammation by measuring faecal calprotectin and systemic inflammatory markers.

Read the detailed description

There is a lack of satisfactory treatments for inflammatory bowel disease (IBD), an excruciatingly debilitating condition which affects 1 in 123 people in the UK (>0.5million). Current treatments have significant negative side effects, affecting quality of life of patients and reducing compliance, leading to exacerbation of symptoms. Dysbiosis in the composition of gut microbiota is one of the leading causes of chronic inflammatory diseases such as inflammatory bowel disease (IBD). Supplementation with dietary components is a promising approach for the treatment of inflammatory bowel disease (IBD) and the use of probiotics for IBD treatment has shown promising effects on consumers' quality of life, they are popular due to their perception as safe, natural treatments but currently marketed products cannot function during active disease. Streptococcus thermophilus (FX856) is an OTC supplement already available in the UK that has a unique ability to survive and thrive during active inflammation, allowing it to promote mucosal healing in the inflamed gut, an area where conventional probiotics have failed. During active inflammation or stress, gut iron levels increase. This iron-rich environment compromises the suitability of conventional probiotic bacteria that have been, and are still, commonly trailed for the relief of symptoms in patients suffering from gut inflammation. Whilst most constituents of the gut microbiome are able to increase growth rate in response to iron, species traditionally employed as probiotics, such as lactobacilli and bifidobacteria, are unable to use iron as a growth factor; they are outcompeted under high iron conditions and cannot have a beneficial effect. Unlike most bacterial strains used as probiotics, FX856 can maintain growth within an iron-rich environment, as observed in the inflamed intestine. Faecal calprotectin is considered a suitable non-invasive surrogate marker of intestinal inflammation in inflammatory bowel disease and is reported to be increased in obese individuals. Consequently, this study will determine how the probiotic FX856 interacts with the gut and immune system to reduce inflammation. A 2-way crossover intervention study will be conducted with FX856 (4 weeks) in an overweight and obese population, as such individuals are likely to have chronic mild gut inflammation and examine markers of faecal calprotectin and circulating inflammatory markers.

Being tested
Probiotic Arm, Placebo Arm
Keywords
Obesity, gut inflammation, gastrointestinal symptoms, microbiota, metabolome, overweight
Medical subject headings
Overweight, Obesity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic ArmDietary supplement

    1 x10^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.

  • Placebo ArmDietary supplement

    corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule.

Study groups in NCT07253155
Study groupRoleWhat they receive
Probiotic ArmExperimentalProbiotic supplement arm, 2 capsules consumed/day for a period of 28 days.
Receives: Dietary Supplement: Probiotic Arm
Placebo ArmPlacebo comparatorPlacebo supplement arm, 2 capsules consumed/day for a period of 28 days.
Receives: Dietary Supplement: Placebo Arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Assess effects of FX856 on faecal calprotectin

    The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.

    Measured: Change over 28 days comparison between treatments

Secondary outcomes (11)
  1. Assess effect of FX856 treatment on gastrointestinal symptoms

    Measured by questionnaire rated on scale from 0 (Dose not bother me at all) to 10 (Is as bad as I can imagine)

    Measured: Change over 28 days comparison between treatments

  2. Assess effect of FX856 on circulating inflammatory cytokines IFN-γ

    Measured by ELISA

    Measured: Change over 28 days comparison between treatments

  3. Assess effect of FX856 on circulating inflammatory cytokines IL-1β

    Measured by ELISA

    Measured: Change over 28 days comparison between treatments

  4. Assess effect of FX856 on circulating inflammatory cytokines IL-6

    Measured by ELISA

    Measured: Change over 28 days comparison between treatments

  5. Assess effect of FX856 on circulating inflammatory cytokines TNF-α

    Measured by ELISA

    Measured: Change over 28 days comparison between treatments

  6. Assess effect of FX856 on Cholesterol

    Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.

    Measured: Change over 28 days comparison between treatments

  7. Assess effect of FX856 on LDL cholesterol

    Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. LDL concentrations calculated using the Friedewald formula.

    Measured: Change over 28 days comparison between treatments

  8. Assess effect of FX856 on HDL cholesterol

    Measured via ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.

    Measured: Change over 28 days comparison between treatments

  9. Assess effects of FX856 on microbiota

    The composition of gut microbiota from faecal samples will be measured by NGS pre and post consumption in all participants to determine if FX856 consumption alters the gut microbiota.

    Measured: Change over 28 days comparison between treatments

  10. Assess effects of FX856 on faecal metabolome

    The faecal metabolome from faecal samples will be measured by untargeted mass spec pre and post consumption in all participants to determine if FX856 consumption alters the faecal metabolome.

    Measured: Change over 28 days comparison between treatments

  11. Assess effects of FX856 on blood metabolome

    The blood metabolome will be measured by untargeted mass spec pre and post consumption in all participants to determine if FX856 consumption alters the blood metabolome.

    Measured: Change over 28 days comparison between treatments

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start14 Oct 2025
  3. Primary completion1 Sep 2028 (estimated)
  4. Study completion1 Sep 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07253155
Sponsor's protocol ID
REC/25/0042
Status last verified
Nov 2025
First submitted
23 Sep 2025
Last updated
28 Nov 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic Arm in people with Gut Inflammation and Overweight and Obese Volunteers, run by University of Ulster at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 28 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Assess effects of FX856 on faecal calprotectin (time frame: Change over 28 days comparison between treatments). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2025.

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