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

Örebro University, Sweden

Status: Not yet enrolling

Conditions: Healthy; Hyperuricemia, Gout

Treatments: Dietary Supplement: BEO001 Probiotic; Dietary Supplement: Placebo; Dietary Supplement: BEO001 Probiotic + Beta-Glucan

Study type: Interventional

Funder types: Other

Identifiers

NCT07366749

2025-07972-01

Details and patient eligibility

About

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.

Enrollment: 8 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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8 participants in 3 patient groups, including a placebo group

Probiotic (BEO001)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: BEO001 Probiotic

Synbiotic (BEO001 + Beta-Glucan)

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: BEO001 Probiotic + Beta-Glucan

Placebo

Placebo Comparator group

Description:

Participants receive placebo powder.

Treatment:

Dietary Supplement: Placebo