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| Name | Class |
|---|---|
| University of Copenhagen | OTHER |
| European Innovation Council | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic (BEO001) | Active Comparator | Participants receive the BEO001 probiotic powder, which contains two probiotic strains |
|
| Synbiotic (BEO001 + Beta-Glucan) | Active Comparator | Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder. |
|
| Placebo | Placebo Comparator | Participants receive placebo powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BEO001 Probiotic | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | ~12-16 hours post-dose (at the gastroscopy visit). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | ~12-16 hours post-dose |
| Change in small intestinal glycomic profile after BEO001 intake |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | ~12-16 hours post-dose. |
| Change in blood urate concentrations |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Julia König, PhD | Contact | +46 732702583 | julia.konig@oru.se | |
| Abubakr Omer, PhD | Contact | +46 736691966 | abubakr.omer@oru.se |
| Name | Affiliation | Role |
|---|---|---|
| Robert Brummer, MD, PhD | Örebro universitet | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Örebro University, Campus USO, School of medical sciences | Örebro | Örebro Lan | 703 62 | Sweden |
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.
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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.
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| BEO001 Probiotic + Beta-Glucan | Dietary Supplement | The BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water. |
|
| Placebo | Dietary Supplement | Powder without the active probiotic strains or beta-glucan |
|
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). |
| ~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). | ~12-16 hours post-dose |
Levels of urate in blood . Comparison is made between intervention visits (BEO001 ± beta-glucan vs. placebo). |
| ~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). | ~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). | ~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). | ~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). | ~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). | ~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). | ~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). | ~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). | ~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. | 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. | 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). | Baseline characteristics (single measurement) correlated with outcomes measured ~12-16 hours post-dose. |
| ID | Term |
|---|---|
| D033461 | Hyperuricemia |
| D006073 | Gout |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D000070657 | Crystal Arthropathies |
| D012216 | Rheumatic Diseases |
| D011686 | Purine-Pyrimidine Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D047071 | beta-Glucans |
| ID | Term |
|---|---|
| D005936 | Glucans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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