The Acute Effects of a Urate-lowering Probiotic Food Supplement/Bacterial Therapeutic on Small Intestinal Transcriptomics and Glycomics in Healthy Subjects
概览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Örebro University, Sweden
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Change in small intestinal transcriptomic profile after BEO001 intake
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
Probiotic (BEO001)
Participants receive the BEO001 probiotic powder, which contains two probiotic strains
干预措施: BEO001 Probiotic (Dietary Supplement)
Synbiotic (BEO001 + Beta-Glucan)
Participants receive the BEO001 probiotic powder plus beta-glucan fiber powder.
干预措施: BEO001 Probiotic + Beta-Glucan (Dietary Supplement)
Placebo
Participants receive placebo powder.
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change in small intestinal transcriptomic profile after BEO001 intake
时间窗: ~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).
次要结局
- Change in small intestinal transcriptomic profile after BEO001+beta-glucan intake.(~12-16 hours post-dose)
- Change in small intestinal glycomic profile after BEO001 intake(~12-16 hours post-dose.)
- Change in small intestinal glycomic profile after BEO001+beta-glucan intake.(~12-16 hours post-dose)