An interventional study of BEO001 Probiotic and BEO001 Probiotic + Beta-Glucan in Healthy and Hyperuricemia, Gout, sponsored by Örebro University, Sweden. Active, not recruiting at 1 site in Sweden. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Örebro University, Sweden · Not applicable, Interventional, and Basic science
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.
240 studies on the registry are indexed under Hyperuricemia; 44 are open to participants now.
This study's planned enrollment of 8 is below the median of 68 across 193 interventional studies indexed under Hyperuricemia.
Browse Hyperuricemia studies →Örebro University, Sweden is the lead sponsor of 86 studies on the registry; 14 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive the BEO001 probiotic powder, which contains two probiotic strains
Dietary Supplement: BEO001 Probiotic
Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder.
Dietary Supplement: BEO001 Probiotic + Beta-Glucan
Participants receive placebo powder.
Dietary Supplement: Placebo
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.
Drug page: Beta-Glucans
The BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water.
Powder without the active probiotic strains or beta-glucan
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).
Time frame: ~12-16 hours post-dose (at the gastroscopy visit).
Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.
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).
Time frame: ~12-16 hours post-dose
Change in small intestinal glycomic profile after BEO001 intake
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).
Time frame: ~12-16 hours post-dose.
Change in small intestinal glycomic profile after BEO001+beta-glucan intake.
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).
Time frame: ~12-16 hours post-dose
Change in small intestinal mucosal microbiome composition and function.
Microbial community profile and functional gene content (shotgun metagenomics) in duodenal biopsies. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Change in blood urate concentrations
Levels of urate in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose
Change in blood creatinine
Levels of creatinine in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose
Change in blood metabolites and enzymes related to urate and inflammation.
Concentrations of targeted metabolites and enzymes (including short-chain fatty acids) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Change in Liver enzyme concentrations
Levels of standard liver function enzymes (e.g., ALT, AST) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Change in blood lipid profile.
Standard lipid panel measurements in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose
Change in the blood level of certain inflammatory cytokines
Levels of certain inflammatory cytokines in blood will be measured. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Change in blood level of C-reactive protein (hsCRP)
Levels of high-sensitivity C-reactive protein (hsCRP) in blood. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose
Change in blood plasma glycomic profile
N-glycan profile of total plasma proteins. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Change in breath volatile organic compounds (VOCs).
Profile of VOCs related to metabolism and inflammation in exhaled breath. Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo).
Time frame: ~12-16 hours post-dose.
Difference in glycomic profiles across biological sample types.
Comparison of glycomics profiles from baseline rectal swabs, baseline faecal samples, and post-intervention intestinal biopsies.
Time frame: Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Difference in microbiome across biological sample types
Comparison of microbiome composition and function from baseline rectal swabs, baseline faecal samples, and post-intervention intestinal biopsies.
Time frame: Rectal/faecal: Baseline (pre-intervention). Biopsies: ~12-16 hours post-dose.
Correlation between outcomes and baseline characteristics.
Analysis of associations between selected outcomes and screening/baseline characteristics (microbiome, metabolomics, glycomics, dietary patterns, genetic factors).
Time frame: Baseline characteristics (single measurement) correlated with outcomes measured ~12-16 hours post-dose.
Plan to share: Undecided — According to Swedish ethics regulations, IPD cannot be shared without an approved ethics application from the National Swedish Ethics Authority. An ethical permit can only be obtained for research being conducted within Sweden.
No publications or documents are linked to this record.
Ran from Apr 2026 to primary completion in Sep 2026, 5 months.
Of 26 interventional studies with no phase under Hyperuricemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 34. This study's 5 months is below that.
Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 20, 2026: start Feb 2026 → Apr 2026, primary completion Jun 2026 → Sep 2026 and completion Jul 2026 → Jun 2027.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-Glucans
Örebro University, Sweden