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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorÖrebro University, Sweden

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • BEO001 Probiotic
  • BEO001 Probiotic + Beta-Glucan
  • Placebo

Treatment groups

8 Participants
are divided into 3 treatment groups

Sponsors and collaborators

Örebro University, Sweden

Lead sponsor

University of Copenhagen

Collaborator

European Innovation Council

Collaborator