Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Functional dyspepsia symptoms
研究概览
简要总结
The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.
详细描述
Sixty volunteers with functional GI disorders (Functional dyspepsia according to Rome-III criteria) will be recruited for a randomised, double-blind, placebo-controlled, two-arm parallel study in which the effect upon the gastrointestinal function of a probiotic mix containing bifidobacteria and lactobacilli (manufactured by Biopolis SL) will be compared with placebo (maltodextrin). The study design includes a 4 week run-in period, in which the volunteers will not consume any probiotics/prebiotics, followed by a 4 weeks intervention period (a daily capsule of placebo or probiotic) and an 8 weeks washout period. At the beginning/end of each period questionnaires in gastrointestinal function, dyspepsia related symptoms and diet will be carried out. A serum sample will be taken for cytokine levels determination. A faecal sample will be taken for 16S microbial population profiling and for determining the faecal levels of Bifidobacterium, Bacteriodes, Faecalibacterium, Akkermansia, Lactobacillus and Blautia by qPCR and the concentration of the main bacterial metabolites; acetate, propionate and butyrate by gas-chromatography.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria
排除标准
- •Celiac disease or other organic GI disease
- •Orthorexia nervosa or other eating disorders
- •Special dietary patterns (vegans, vegetarians, macrobiotic, exclusion diets, etc.)
- •Extreme BMI (<18,8 or > 39,9)
- •Metabolic disorders
- •Positive Helicobacter pylori test
- •Congenital IgA deficiency
- •Lactose malabsorption/intolerance
- •Scleroderma, CREST, lupus or other connective tissue diseases
- •Previous GI surgery or neoplastic disease
- •Treatment with non steroidal anti-inflammatory drugs and/or acetyl salicylic acid.
- •Pregnancy
- •Menopause
结局指标
主要结局
Functional dyspepsia symptoms
时间窗: 3 months
Physician determined symptoms according to Rome III criteria.
次要结局
- Dyspepsia associated quality of life(3 months)
- Serum IL-10 levels(3 months)
- Fecal levels of Bifidobacterium(3 months)
- Fecal levels of Bacteroides(3 months)
- Serum IL-4 levels(3 months)
- Fecal levels of Lactobacillus(3 months)
- Fecal levels of Faecalibacterium(3 months)
- Serum IFN-gamma levels(3 months)
- Fecal levels of Blautia(3 months)
- Serum TNF-alpha levels(3 months)
- Relative proportions of the main microbial groups of the intestinal microbiota(3 months)
- Serum IL-12 levels(3 months)
- Serum TGF-beta levels(3 months)
- Fecal levels of Akkermansia(3 months)