Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects (Bugs4U-MoA)

January 16, 2026 updated by: Örebro University, Sweden

The Acute Effects of a Urate-lowering Probiotic Food Supplement/Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects

This is a pilot study investigating how a novel probiotic supplement (BEO001), with and without a dietary fiber (beta-glucan), affects the lining of the small intestine in healthy people. The main goal is to see if a single dose of the probiotic changes gene activity (transcriptomics) and sugar molecule patterns (glycomics) in the gut. Eight participants will take three different treatments (placebo, probiotic alone, probiotic with fiber) in a random order, with at least 10 days between each. A gastroscopy to collect small intestinal tissue samples (biopsies) is performed the morning after each treatment. Blood and breath samples are also collected at these visits to explore effects on metabolism and inflammation. To understand how different sampling methods compare, participants collect stool samples and simple rectal swabs at home before any treatment. Researchers analyze the sugar molecules and bacteria in these samples, then compare them to each other and to the gut tissue samples collected after treatment. This helps determine if easier-to-collect samples can provide similar information to gut biopsies. The study also aims to combine all data (including genetics and diet) to identify key targets for future research and to attempt to grow 'mini-gut' organoids from the biopsies. The results will help design larger future studies in people with high uric acid levels.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

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.

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.
8

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Sweden
    • Örebro Lan
      • Örebro, Örebro Lan, Sweden, 703 62

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Signed informed consent.
  • Age 18-60 years.
  • BMI 18.5 - 29.9 kg/m².
  • Willing to avoid probiotics, fermented foods, and maintain stable diet/lifestyle for the study duration.

Exclusion Criteria:

  • Chronic GI, inflammatory, metabolic (including renal), or significant psychiatric disease.
  • Acute infection/allergy within 2 weeks.
  • Regular use of NSAIDs, antibiotics, steroids, immunomodulators.
  • Alcohol >9 units/week.
  • Use of recreational drugs, tobacco, or nicotine.
  • Known allergy to local anesthetics or sedatives for gastroscopy.
  • Bleeding disorder or use of anticoagulants.
  • Use of probiotics or antibiotics within 4 weeks prior.
  • Pregnancy, breastfeeding, or planning pregnancy.
  • Any condition deemed by investigator to compromise safety or data integrity

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

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.
Active Comparator: Probiotic (BEO001)
Participants receive the BEO001 probiotic powder, which contains two probiotic strains
Dietary supplement: BEO001 Probiotic
A mixture of two probiotic strains. Total dose ≥5x10^10 CFU of each strain per intervention day. Administered as a powder mixed with water, consumed in several portions.
Active Comparator: Synbiotic (BEO001 + Beta-Glucan)
Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder.
Dietary supplement: BEO001 Probiotic + Beta-Glucan
The BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water.
Placebo Comparator: Placebo
Participants receive placebo powder.
Dietary supplement: Placebo
Powder without the active probiotic strains or beta-glucan

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
Change in small intestinal transcriptomic profile after BEO001 intake
Time Frame: ~12-16 hours post-dose (at the gastroscopy visit).
Gene expression profile (analyzed by RNA sequencing) in duodenal mucosal biopsies collected the morning after a single evening dose of BEO001 probiotic. Comparison is made between intervention visits (BEO001 vs. placebo).
~12-16 hours post-dose (at the gastroscopy visit).

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
Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.
Time Frame: ~12-16 hours post-dose
Gene expression profile in duodenal biopsies after a single evening dose of BEO001 with beta-glucan. Comparison is made between intervention visits (BEO001+beta-glucan vs. placebo).
~12-16 hours post-dose
Change in small intestinal glycomic profile after BEO001 intake
Time Frame: ~12-16 hours post-dose.
N- and O-glycan profiles (analyzed by LC-MS) in duodenal biopsies after a single evening dose of BEO001. Comparison is made between intervention visits (BEO001 vs. placebo).
~12-16 hours post-dose.
Change in small intestinal glycomic profile after BEO001+beta-glucan intake.
Time Frame: ~12-16 hours post-dose
N- and O-glycan profiles in duodenal biopsies after a single evening dose of BEO001 with beta-glucan. Comparison is made between intervention visits (BEO001 +beta-glucan vs. placebo).
~12-16 hours post-dose

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in small intestinal mucosal microbiome composition and function.
Time Frame: ~12-16 hours post-dose.
Microbial community profile and functional gene content (shotgun metagenomics) in duodenal biopsies. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Change in blood urate concentrations
Time Frame: ~12-16 hours post-dose
Levels of urate in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose
Change in blood creatinine
Time Frame: ~12-16 hours post-dose
Levels of creatinine in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose
Change in blood metabolites and enzymes related to urate and inflammation.
Time Frame: ~12-16 hours post-dose.
Concentrations of targeted metabolites and enzymes (including short-chain fatty acids) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Change in Liver enzyme concentrations
Time Frame: ~12-16 hours post-dose.
Levels of standard liver function enzymes (e.g., ALT, AST) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Change in blood lipid profile.
Time Frame: ~12-16 hours post-dose
Standard lipid panel measurements in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose
Change in the blood level of certain inflammatory cytokines
Time Frame: ~12-16 hours post-dose.
Levels of certain inflammatory cytokines in blood will be measured. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Change in blood level of C-reactive protein (hsCRP)
Time Frame: ~12-16 hours post-dose
Levels of high-sensitivity C-reactive protein (hsCRP) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose
Change in blood plasma glycomic profile
Time Frame: ~12-16 hours post-dose.
N-glycan profile of total plasma proteins. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Change in breath volatile organic compounds (VOCs).
Time Frame: ~12-16 hours post-dose.
Profile of VOCs related to metabolism and inflammation in exhaled breath. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
~12-16 hours post-dose.
Difference in glycomic profiles across biological sample types.
Time Frame: Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Comparison of glycomics profiles from baseline rectal swabs, baseline faecal samples, and post-intervention intestinal biopsies.
Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Difference in microbiome across biological sample types
Time Frame: Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Comparison of microbiome composition and function from baseline rectal swabs, baseline faecal samples, and post-intervention intestinal biopsies.
Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Correlation between outcomes and baseline characteristics.
Time Frame: Baseline characteristics (single measurement) correlated with outcomes measured ~12-16 hours post-dose.
Analysis of associations between selected outcomes and screening/baseline characteristics (microbiome, metabolomics, glycomics, dietary patterns, genetic factors).
Baseline characteristics (single measurement) correlated with outcomes measured ~12-16 hours post-dose.

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.
Örebro University, Sweden

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.
University of Copenhagen
European Innovation Council

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.
  • Study Director: Robert Brummer, MD, PhD, Örebro universitet

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 (Estimated)

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.
February 1, 2026

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.
June 1, 2026

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.
July 1, 2026

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).
January 9, 2026

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.
January 16, 2026

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.
January 26, 2026

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.
January 26, 2026

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.
January 16, 2026

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.
January 1, 2026

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.
  • 2025-07972-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

According to Swedish ethics regulations, IPD cannot be shared without an approved ethics application from the National Swedish Ethics Authority. An ethical permit can only be obtained for research being conducted within Sweden.

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.

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