Safety, Tolerability, and Biosignature of Humanized Prebiotics in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean Composite PROMIS Maximum Scores
研究概览
简要总结
This study aims to establish the safety of a 15 g/day dose of pure prebiotics ß(1-4) galacto-oligosaccharides (GOS) and GOS enriched with N-Acetyl-D-lactosamine, a building block of gut glycoproteins and human milk oligosaccharides (LAcNac, humanized GOS, hGOS) in healthy adult individuals. The safety and tolerability of the dose and the biological signature of GOS and hGOS in healthy adults will be established through a pilot clinical trial to assess GOS and hGOS effects vs placebo on (i) gastrointestinal adverse effects as measured by the Gastrointestinal Symptom and Severity Checklist (GSSC), (ii) increased abundance of beneficial gut bacteria and restoration of the gut microbiome saccharolytic potential, (iii) modulation of biomarkers of inflammation and (iv) evaluation of intestinal barrier function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All participants will be nonsmokers and well-nourished according to standard anthropometric criteria with BMI between 18.5 and
- •Individuals must be able to give informed consent.
- •Subjects willing and able to:
- •consume prebiotics or placebo preparations for a period of 4 weeks.
- •Record daily food consumption using the Centers for Disease Control and Prevention (CDC) My Food Diary questionnaire.
- •provide stool and blood (via venipuncture) samples.
- •Enrollment will not be restricted based on race, ethnicity, or gender. The subject population will reflect the population providing a broad selection of individuals to allow enrollment of subjects from all races, ethnicities, and genders, as represented in North Carolina state.
排除标准
- •Less than 18 years of age or older than 55 years of age
- •Pregnant or breastfeeding
研究组 & 干预措施
lactosamine-enriched "humanized" galacto-oligosaccharides (hGOS)
The treatment will consist of 10-15 g/day of hGOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
干预措施: "Humanized" galacto-oligosaccharides (hGOS) (Dietary Supplement)
galacto-oligosaccharides (GOS)
The treatment will consist of 10-15 g/day of GOS, which will be provided to participants as a powder that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks since the research team has shown in adult individuals that a 4-wk period allows for the observation of changes to the gut microbiome. The study will end after the second time-point sample collection at 4 weeks.
干预措施: Galacto-oligosaccharides (GOS) (Dietary Supplement)
Placebo
The placebo comparator treatment will consist of 10-15 g/day placebo powder, that can be added to any non-alcoholic beverage. The intervention will last for 4 weeks to mirror the treatment arms. The study will end after the second time-point sample collection at 4 weeks.
干预措施: Matching Placebo (Other)
结局指标
主要结局
Mean Composite PROMIS Maximum Scores
时间窗: Between week 0 (Baseline) and week 4
The overall Patient-Reported Outcomes Measurement Information System (PROMIS) score symptom (composite) was calculated as follows: Individual items from the GI questionnaire were grouped into seven symptom domains: abdominal pain, bloating, abdominal distension, flatulence, constipation, diarrhea, and nausea. Each item was rated on a 0-4 scale (0 = "never," 4 = "always"). For each participant at each visit (week 0 and week 4), a domain-specific symptom severity score was defined as the maximum item score within that domain (range 0-4). Using the seven domain severity scores, a composite PROMIS maximum GI measure was calculated for each visit. Composite PROMIS maximum was defined as the maximum severity score cumulatively across all seven domains, representing the participant's worst GI symptoms at that time point. The range of the composite PROMIS maximum score is 0-28 with lower scores representing lowest GI symptoms.
次要结局
- Mean Percent Change in Relative Abundance of Beneficial Bacteria(Between week 0 (Baseline) and week 4)
- Interleukin-1α Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-1ß Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-6 Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-8 Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-12 Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-17 Concentration(Between week 0 (Baseline) and week 4)
- Interleukin-18 Concentration(Between week 0 (Baseline) and week 4)
- Tumor Necrosis Factor Alpha (TNF-α) Concentration(Between week 0 (Baseline) and week 4)
- Interferon Gamma (IFNγ) Concentration(Between week 0 (Baseline) and week 4)
- Change in C-Reactive Protein Concentration(Between week 0 (Baseline) and week 4)
- Change in Zonulin Concentration(Between week 0 (Baseline) and week 4)