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

November 26, 2025 updated by: University of Ulster
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Coleraine, United Kingdom, BT52 1SA
        • Ulster University, Human Intervention Studies Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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%)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Arm
Probiotic supplement arm, 2 capsules consumed/day for a period of 28 days.
Dietary supplement: Probiotic Arm
1 x10^9 cfu Streptococcus thermophilus (FX856), corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule.
Placebo Comparator: Placebo Arm
Placebo supplement arm, 2 capsules consumed/day for a period of 28 days.
Dietary supplement: Placebo Arm
corn starch, anti-caking agent in a hydroxypropylmethycellulose & pectin capsule.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Change over 28 days comparison between treatments

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Assess effect of FX856 treatment on gastrointestinal symptoms
Time Frame: Change over 28 days comparison between treatments
Measured by questionnaire rated on scale from 0 (Dose not bother me at all) to 10 (Is as bad as I can imagine)
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
Measured by ELISA
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
Measured by ELISA
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
Measured by ELISA
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
Measured by ELISA
Change over 28 days comparison between treatments
Assess effect of FX856 on Cholesterol
Time Frame: Change over 28 days comparison between treatments
Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.
Change over 28 days comparison between treatments
Assess effect of FX856 on LDL cholesterol
Time Frame: Change over 28 days comparison between treatments
Measured by ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays. LDL concentrations calculated using the Friedewald formula.
Change over 28 days comparison between treatments
Assess effect of FX856 on HDL cholesterol
Time Frame: Change over 28 days comparison between treatments
Measured via ILab 650 chemistry analyser using CHOD-PAP/GPO-PAP colorimetric end-point assays.
Change over 28 days comparison between treatments
Assess effects of FX856 on microbiota
Time Frame: Change over 28 days comparison between treatments
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.
Change over 28 days comparison between treatments
Assess effects of FX856 on faecal metabolome
Time Frame: Change over 28 days comparison between treatments
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.
Change over 28 days comparison between treatments
Assess effects of FX856 on blood metabolome
Time Frame: Change over 28 days comparison between treatments
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.
Change over 28 days comparison between treatments

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Ulster

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ferryx Limited

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chris Gill, PhD, Ulster University, Human Intervention Studies Unit, Coleraine, Co. Londonderry, BT52 1SA, United Kingdom.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 14, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 28, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/25/0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gut Inflammation

Clinical Trials on Probiotic Arm

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings