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

NCT07366749 | Not Yet Recruiting

• 1 other identifier: 2025-07972-01
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy; Hyperuricemia, Gout

Keywords

probiotics; gut microbiome; small intestine; transcriptomics; glycomics; urate metabolism

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.

  ~12-16 hours post-dose

• Change in small intestinal glycomic profile after BEO001 intake

  ~12-16 hours post-dose.

• Change in small intestinal glycomic profile after BEO001+beta-glucan intake.

  ~12-16 hours post-dose

Other Outcomes (13)

• Change in small intestinal mucosal microbiome composition and function.

  ~12-16 hours post-dose.

• Change in blood urate concentrations

  ~12-16 hours post-dose

• Change in blood creatinine

  ~12-16 hours post-dose

Study Arms (3)

Probiotic (BEO001)

ACTIVE COMPARATOR

Participants receive the BEO001 probiotic powder, which contains two probiotic strains

Dietary Supplement: BEO001 Probiotic

Synbiotic (BEO001 + Beta-Glucan)

ACTIVE COMPARATOR

Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder.

Dietary Supplement: BEO001 Probiotic + Beta-Glucan

Placebo

PLACEBO COMPARATOR

Participants receive placebo powder.

Dietary Supplement: Placebo

Interventions

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.

Probiotic (BEO001)

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.

Synbiotic (BEO001 + Beta-Glucan)

Placebo DIETARY_SUPPLEMENT

Powder without the active probiotic strains or beta-glucan

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• University of Copenhagen: collaborator
• European Innovation Council: collaborator

Study Sites (1)

Örebro University, Campus USO, School of medical sciences

Örebro, Örebro Lan, 703 62, Sweden

Location

MeSH Terms

Conditions

Hyperuricemia; Gout

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Glucans; Polysaccharides; Carbohydrates

Study Officials

• Robert Brummer, MD, PhD

  Örebro universitet

  STUDY DIRECTOR

Central Study Contacts

Julia König, PhD

CONTACT

+46 732702583; julia.konig@oru.se

Abubakr Omer, PhD

CONTACT

+46 736691966; abubakr.omer@oru.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each participant receives all three interventions in a randomly assigned order. A minimum of 10 days separates each intervention period. This is intended to allow the gut to return to a baseline state and minimize carryover effects.

Study Record Dates

• First Submitted: January 9, 2026
• First Posted: January 26, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: January 26, 2026

Record last verified: 2026-01

Locations

SE (1)