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.
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
- Conditions the study is for
- Gut Inflammation, Overweight and Obese Volunteers
- 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
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.
- Conditions
- Gut Inflammation, Overweight and Obese Volunteers
- 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 group | Role | What they receive |
|---|---|---|
| Probiotic Arm | Experimental | Probiotic supplement arm, 2 capsules consumed/day for a period of 28 days. Receives: Dietary Supplement: Probiotic Arm |
| Placebo Arm | Placebo comparator | Placebo 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.
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)
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
Assess effect of FX856 on circulating inflammatory cytokines IFN-γ
Measured by ELISA
Measured: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-1β
Measured by ELISA
Measured: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-6
Measured by ELISA
Measured: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines TNF-α
Measured by ELISA
Measured: Change over 28 days comparison between treatments
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
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
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
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
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
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.
- First posted28 Nov 2025
- Study start14 Oct 2025
- Primary completion1 Sep 2028 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gut InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Ulster
- Sponsor type
- University, hospital or other
- Collaborators
- Ferryx Limited
- Responsible party
- Sponsor
- Investigators
- Chris Gill, PhD, Principal investigator, Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
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
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Probiotics Use and Preventing Gastrointestinal Symptoms in People Living With Overweight and Obesity.
- ClinicalTrials.gov ID
- NCT07253155
- Acronym / sponsor ID
- REC/25/0042
- Conditions
- Gut Inflammation, Overweight and Obese Volunteers
- Keywords
- Obesity, gut inflammation, gastrointestinal symptoms, microbiota, metabolome, overweight
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of UlsterUniversity, hospital or other
- Collaborators
- Ferryx Limited
- Study start
- 14 Oct 2025 (actual)
- Primary completion
- 1 Sep 2028 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic Arm | Experimental | Dietary Supplement: Probiotic ArmProbiotic supplement arm, 2 capsules consumed/day for a period of 28 days. |
| Placebo Arm | Placebo comparator | Dietary Supplement: Placebo ArmPlacebo supplement arm, 2 capsules consumed/day for a period of 28 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Probiotic Arm1 x10^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule. | Dietary supplement | Probiotic Arm |
| Placebo Armcorn starch, anti-caking agent in a hydroxypropylmethycellulose \& pectin capsule. | Dietary supplement | Placebo Arm |
Primary outcome
Assess effects of FX856 on faecal calprotectin
Time frame: Change over 28 days comparison between treatments
The level of calprotectin in faecal samples will be measured by immunoassay in all participants to determine if FX856 consumption can decrease it.
11 secondary outcomes
Assess effect of FX856 treatment on gastrointestinal symptoms
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IFN-γ
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-1β
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines IL-6
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on circulating inflammatory cytokines TNF-α
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on Cholesterol
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on LDL cholesterol
Time frame: Change over 28 days comparison between treatments
Assess effect of FX856 on HDL cholesterol
Time frame: Change over 28 days comparison between treatments
Assess effects of FX856 on microbiota
Time frame: Change over 28 days comparison between treatments
Assess effects of FX856 on faecal metabolome
Time frame: Change over 28 days comparison between treatments
Assess effects of FX856 on blood metabolome
Time frame: Change over 28 days comparison between treatments
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chris Gill, PhD principal investigator
Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.
1 site in 1 country: see every site and its status.
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.