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

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: Not yet recruiting
• Conditions: Healthy; Hyperuricemia, Gout
• Intervention / Treatment: Dietary supplement: BEO001 Probiotic; Dietary supplement: BEO001 Probiotic + Beta-Glucan; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 8
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Julia König, PhD; Phone Number: +46 732702583; Email: julia.konig@oru.se
• Study Contact Backup: Name: Abubakr Omer, PhD; Phone Number: +46 736691966; Email: abubakr.omer@oru.se

Study Locations

• Sweden
  • Örebro Lan
    • Örebro, Örebro Lan, Sweden, 703 62
      • Örebro University, Campus USO, School of medical sciences
      • Contact: Abubakr Omer, PhD; Phone Number: 0736691966; Email: abubakr.omer@oru.se
      • Contact: Georgia Chatonidi, PhD; Email: georgia.chatonidi@oru.se

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Change in small intestinal transcriptomic profile after BEO001 intake	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

Outcome Measure	Measure Description	Time Frame
Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.	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	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.	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

Outcome Measure	Measure Description	Time Frame
Change in small intestinal mucosal microbiome composition and function.	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	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	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.	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	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.	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	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)	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	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).	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.	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	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.	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

• Sponsor: Örebro University, Sweden
• Collaborators: University of Copenhagen; European Innovation Council
• Investigators: Study Director: Robert Brummer, MD, PhD, Örebro universitet

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: January 9, 2026
• First Submitted That Met QC Criteria: January 16, 2026
• First Posted (Actual): January 26, 2026

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 16, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: probiotics; gut microbiome; small intestine; transcriptomics; glycomics; urate metabolism
• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Pathologic Processes; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Gout; Hyperuricemia; Carbohydrates; Polysaccharides; Glucans; beta-Glucans
• Other Study ID 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