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NCT Number: NCT07366749

Acute Effects of a Urate-lowering 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.

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Key information

Conditions

Healthy Arthritis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Crystal Arthropathies Genetic Diseases, Inborn Gout Hyperuricemia Hyperuricemia, Gout Joint Diseases Metabolic Diseases Metabolism, Inborn Errors Musculoskeletal Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purine-Pyrimidine Metabolism, Inborn Errors Rheumatic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BEO001 Probiotic

Dietary Supplement

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.

BEO001 Probiotic + Beta-Glucan

Dietary Supplement

The BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water.

Placebo

Dietary Supplement

Powder without the active probiotic strains or beta-glucan

Primary outcomes

  1. 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).

Secondary outcomes

  1. 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).

  2. 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).

  3. 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).

Other outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

  7. 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).

  8. 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).

  9. 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).

  10. 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).

  11. 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.

  12. 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.

  13. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Abubakr Omer, PhD

CONTACT

[email protected]

+46 736691966

Julia König, PhD

CONTACT

[email protected]

+46 732702583

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • European Innovation Council
  • University of Copenhagen

Registry information

Official study title

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

Acronym: Bugs4U-MoA

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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