NCT02018900已完成4 期
The Effects of the Synbiotic Ecologic 825/scFOS on Intestinal Barrier Function
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Sugar recovery in urine, as indicator of intestinal permeability
研究概览
简要总结
In the present pilot study, the investigators will study the effects of a novel synbiotic, which is a mix of probiotics (Ecologic 825) in the presence of a prebiotic (short chain fructo-oligosaccharide (scFOS)), on mucosal integrity, overall microbiota changes along the gastrointestinal-tract and the mucosal immune response. The investigators hypothesize that the synbiotic Ecologic 825/scFOS will significantly affect the intestinal permeability and modulate the immune system in humans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Based on medical history and previous self-admitted examination, no gastrointestinal complaints can be defined
- •Age between 18 and 65 years
- •Body Mass Index (BMI) between 20 and 30 kilogram/m2
排除标准
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, head, ears, eyes, nose, throat (HEENT), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological diseases, allergy, major surgery and/or laboratory assessments which might limit participation in or completion of the study protocol. - Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- •Administration of probiotic supplements, investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), in the 180 days prior to the study
- •Use of antibiotics in the 90 days prior to the study
- •Abdominal surgery interfering with gastrointestinal function, upon judgment of the principle investigator)
- •Pregnancy, lactation
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •Blood donation within 3 months before or after the study period
- •Self-admitted Human immunodeficiency virus-positive state
- •History of any side effects towards intake of pro- or prebiotic supplements of any kind
结局指标
主要结局
Sugar recovery in urine, as indicator of intestinal permeability
时间窗: Baseline and after 2 weeks intervention
次要结局
- Biomarkers of immune modulation; plasma levels of Tumor necrosis factor alpha , Interleukin-1 beta, Interleukin-6, Interleukin-8, Interleukin-17, Monocyte chemoattractant protein-1 and Macrophage inflammatory protein-1a(Baseline and after 2 weeks intervention)
- Relative abundance of commensal rat ileum bacterium (CRIB) by quantitative polymerase chain reaction (qPCR)(Baseline and after 2 weeks intervention)
- Barcoded pyrosequencing of 16S rRNA genes of the microbiota(Baseline and after 2 weeks intervention)
- Metatranscriptomics of the microbiota(Baseline and after 2 weeks intervention)
- 10 item gastrointestinal symptom diary(Baseline and after 2 weeks intervention)
- Quantitative Insights Into Microbial Ecology (QIIME) of the microbiota(Baseline and after 2 weeks intervention)
研究者
研究点 (2)
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