Healthy, Hyperuricemia, Gout
Conditions
Keywords
probiotics, gut microbiome, small intestine, transcriptomics, glycomics, urate metabolism
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.
Interventions
DIETARY_SUPPLEMENTBEO001 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_SUPPLEMENTBEO001 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_SUPPLEMENTPlacebo
Powder without the active probiotic strains or beta-glucan
Sponsors
Örebro University, Sweden
University of Copenhagen
European Innovation Council
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in small intestinal transcriptomic profile after BEO001 intake | ~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
| Measure | Time frame | Description |
|---|---|---|
| Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake. | ~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). |
| Change in small intestinal glycomic profile after BEO001 intake | ~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). |
| Change in small intestinal glycomic profile after BEO001+beta-glucan intake. | ~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). |
Countries
Sweden
Contacts
CONTACTJulia König, PhD
CONTACTAbubakr Omer, PhD
STUDY_DIRECTORRobert Brummer, MD, PhD
Örebro universitet
Outcome results
None listed