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

Official title

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

Overview

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.

Interventions

• 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.
• 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.
• Dietary supplement Placebo
  Powder without the active probiotic strains or beta-glucan

Primary outcome measures

• Change in small intestinal transcriptomic profile after BEO001 intake [Time frame: ~12-16 hours post-dose (at the gastroscopy visit).]

Secondary outcome measures (3)

• Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake. [Time frame: ~12-16 hours post-dose]
• Change in small intestinal glycomic profile after BEO001 intake [Time frame: ~12-16 hours post-dose.]
• Change in small intestinal glycomic profile after BEO001+beta-glucan intake. [Time frame: ~12-16 hours post-dose]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Quadruple blind

Primary purpose

Basic science

Study locations

Sweden · 1 center

• Örebro University, Campus USO, School of medical sciences — Örebro

Identifiers

NCT: NCT07366749 · 2025-07972-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗