Effects of Fasting and Hydro Colon Therapy Plus Probiotics on Abundance and Diversity of GI Microbiota in Intolerances and Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
研究概览
简要总结
Consequences of Colon Hydrotherapy plus probiotic intervention on composition of GI microbiota and well being are analysed in subjects claiming GI inconveniences due to Irritable Bowel Syndrome or food intolerances.
详细描述
Study objectives: Analysis of consequences of Hydro Colon Therapy plus probiotic intervention on GI microbiota and well being.
Study group: 78 subjects, inclusion criteria: 20-50yrs; under consultation at doctors or nutritionists because of claimed food inconveniences or Irritable Bowel Syndrome. exclusion criteria: antibiotics treatment and specified complex diseases.
Intervention: Hydro colon therapy 2- 5 washes within 3 weeks. probiotic intervention after end of Hydro colon therapy for 6 weeks ( DUOLAC® bacterial strains per capsule: Lactobacillus plantarum, Streptococcus thermophiles, Lactobacillus acidophilus, Lactobacillus rhamnosus, Bifidobacterium lactis, Bifidobacterium longum, and Bifidobacterium breve, fructooligosaccharides, 200 µg folic acid, 2.50 µg vitamin B12 and 55 µg selenium (all amounts corresponding to 100% of daily requirement). Control group: Vitamin B complex: 10µg cobalamin, 450µg folic acid, and 55 µg selenium.
Sample collection: standardized Feces collection, T1, before colon hydrotherapy, T2, immediately after colon hydrotherapy 2-5 washes of fasting ; T3, after six weeks of probiotic or Control intervention Analysis: standardizes food frequency questionnaire before and after intervention.
Feces analysis based on 16 S ribosomal DNA (rDNA) PCR DGGE and quantitative PCR (qPCR) and bioinformatic analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects under consultation at doctors or nutritionists for Inflammatory Bowel Syndrome (IBD) of food intolerances
排除标准
- •Pregnancy
- •Antibiotic therapy 0,5 yrs before start
- •Hormone therapies
- •Malignant diseases
- •Subjects were asked to avoid dietary supplements 4 weeks before and during the study.
结局指标
主要结局
microbiota structure, using 16 S ribosomal based gradient electrophoresis ( DGGE)
时间窗: 7- 8 weeks hydro colon washes plus probiotic
Microbiota were analysed for abundance of main microbiota groups and microbiota diversity using 16 S ribosomal based gradient electrophoresis ( DGGE). Abundance is shown in DNA copies/g feces; diversity as number of bands/ sample and by bioinformatic analysis
Gastrointestinal comfort, measured by Visual Analog Scale
时间窗: 7- 8 weeks hydro colon washes plus probiotic
Gastrointestinal comfort was analysed by a standardised questionnaire. Pain was measured by Visual Analog Scale
次要结局
未报告次要终点
研究者
Univ. Doz. Dr. Alexander Haslberger
Univ. Dozent
University of Vienna