HealthyBugs4U-MoANCT07366749
Acute Effects of a Urate-lowering Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
A study testing BEO001 Probiotic and BEO001 Probiotic + Beta-Glucan in people with Healthy and Hyperuricemia, Gout, run by Örebro University, Sweden at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Hyperuricemia, Gout
- What is being tested?
- BEO001 Probiotic and BEO001 Probiotic + Beta-Glucan
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteSweden
- Study dates
- 9 Apr 2026to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Örebro University, Campus USO, School of medical sciences
Örebro, Örebro Lan, 703 62
About this study
Official title: The Acute Effects of a Urate-lowering Probiotic Food Supplement/Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
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.
- Conditions
- Healthy, Hyperuricemia, Gout
- Being tested
- BEO001 Probiotic, BEO001 Probiotic + Beta-Glucan, Placebo
- Keywords
- probiotics, gut microbiome, small intestine, transcriptomics, glycomics, urate metabolism
- Medical subject headings
- Hyperuricemia, Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BEO001 ProbioticDietary 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.
BEO001 Probiotic + Beta-GlucanDietary supplement
The BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water.
PlaceboDietary supplement
Powder without the active probiotic strains or beta-glucan
| Study group | Role | What they receive |
|---|---|---|
| Probiotic (BEO001) | Active comparator | Participants receive the BEO001 probiotic powder, which contains two probiotic strains Receives: Dietary Supplement: BEO001 Probiotic |
| Synbiotic (BEO001 + Beta-Glucan) | Active comparator | Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder. Receives: Dietary Supplement: BEO001 Probiotic + Beta-Glucan |
| Placebo | Placebo comparator | Participants receive placebo powder. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: ~12-16 hours post-dose (at the gastroscopy visit).
Secondary outcomes (3)
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).
Measured: ~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).
Measured: ~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).
Measured: ~12-16 hours post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start9 Apr 2026
- Primary completion25 Sep 2026
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Örebro University, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- University of Copenhagen, European Innovation Council
- Responsible party
- Sponsor
- Investigators
- Robert Brummer, MD, PhD, Study director, Örebro universitet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366749
- Sponsor's protocol ID
- 2025-07972-01
- Other IDs
- 2025
- Acronym
- Bugs4U-MoA
- Status last verified
- Oct 2026
- First submitted
- 9 Jan 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of a Urate-lowering Probiotic Food Supplement/Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
- ClinicalTrials.gov ID
- NCT07366749
- Acronym / sponsor ID
- Bugs4U-MoA / 2025-07972-01
- Conditions
- Healthy, Hyperuricemia, Gout
- Keywords
- probiotics, gut microbiome, small intestine, transcriptomics, glycomics, urate metabolism
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Örebro University, SwedenUniversity, hospital or other
- Collaborators
- University of Copenhagen, European Innovation Council
- Study start
- 9 Apr 2026 (actual)
- Primary completion
- 25 Sep 2026 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Probiotic (BEO001) | Active comparator | Dietary Supplement: BEO001 ProbioticParticipants receive the BEO001 probiotic powder, which contains two probiotic strains |
| Synbiotic (BEO001 + Beta-Glucan) | Active comparator | Dietary Supplement: BEO001 Probiotic + Beta-GlucanParticipants receive the BEO001 probiotic powder plus beta-glucan fiber powder. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboParticipants receive placebo powder. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BEO001 ProbioticA 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 | Probiotic (BEO001) |
| BEO001 Probiotic + Beta-GlucanThe BEO001 probiotic (as above) co-administered with 3g of a food-grade beta-glucan fiber. Both are powders mixed with water. | Dietary supplement | Synbiotic (BEO001 + Beta-Glucan) |
| PlaceboPowder without the active probiotic strains or beta-glucan | Dietary supplement | Placebo |
Primary outcome
Change in small intestinal transcriptomic profile after BEO001 intake
Time frame: ~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).
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Brummer, MD, PhD study director
Örebro universitet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BEO001 Probiotic and BEO001 Probiotic + Beta-Glucan in people with Healthy and Hyperuricemia, Gout, run by Örebro University, Sweden at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in small intestinal transcriptomic profile after BEO001 intake (time frame: ~12-16 hours post-dose (at the gastroscopy visit).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2026.