A Placebo-controlled Cross-over Randomized Study to Investigate the Impact of Butyricicoccus Pullicaecorum in Healthy Human Volunteers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements
研究概览
简要总结
During this project the safety, tolerability and effect on gut microbiota of oral administration of Butyricicoccus pullicaecorum was investigated in healthy human volunteers by a placebo-controlled cross-over randomized study.
详细描述
Intervention periods were 4 weeks, with daily intake of 1 capsule. Wash-out periods were 3 weeks.
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
- Triple (Participant, 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
- •BMI between 18 and 28 kg/m²
- •Good general health
- •Regular eating pattern (3 meals/day on at least 5 days/week)
排除标准
- •Chronic gastrointestinal disease (Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic constipation or chronic diarrhea)
- •Surgery of the gastrointestinal tract (except for an appendectomy)
- •Use of antibiotics during the month preceding the study
- •Use of medication or dietary supplements influencing gut transit or intestinal microbiota during the month preceding the study. Examples of such medication/dietary supplements are antispasmodics (e.g. buscopan), antidiarrheal medication (e.g. imodium), probiotic medication (e.g. lacteol, enterol)
- •Intake of pre- or probiotics during the study or during the month preceding the study
- •Being on a weight-loss diet during the study or during the month preceding the study
- •Extreme dietary habits (e.g. vegan, Atkins diet, Montignac diet)
- •Females who are pregnant, lactating or planning to become pregnant during the study period
研究组 & 干预措施
Placebo (maltodextrin)
Lyophilized maltodextrin, encapsulated with a pH-resistent coating.
干预措施: Maltodextrin (Other)
Butyricicoccus pullicaecorum
Lyophilized Butyricicoccus pullicaecorum 25-3T bacteria, encapsulated with a pH-resistent coating.
干预措施: Butyricicoccus pullicaecorum 25-3T (Dietary Supplement)
结局指标
主要结局
Safety profile of Butyricicoccus pullicaecorum intake (composite outcome measure), measured by abdominal complaints surveys, standard blood tests and fecal calprotectin measurements
时间窗: 1 year
次要结局
- The effect of Butyricicoccus pullicaecorum intake on gut microbiota composition, measured by 16S rDNA Illumina profiling of the bacterial communities(1 year)
- The effect of Butyricicoccus pullicaecorum intake on gut microbiota activity, measured by GC-MS analysis of the fecal volatile organic compounds(1 year)
研究者
Kristin Verbeke
Professor Kristin Verbeke
KU Leuven