Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Signs and Symptoms, Digestive
- Sponsor
- Biopolis S.L.
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Functional dyspepsia symptoms
- Last Updated
- 9 years ago
Overview
Brief Summary
The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Functional dyspepsia (type postprandial distress or postprandial distress plus epigastric pain) diagnosed according to Rome III criteria
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Functional dyspepsia symptoms
Time Frame: 3 months
Physician determined symptoms according to Rome III criteria.
Secondary Outcomes
- 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)