Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Evaluación Del Efecto Del Suplemento Nutricional probiótico "Biopolis" Sobre la función Gastrointestinal

The purpose of this pilot study is to evaluate whether a probiotic supplement improves gastrointestinal (GI) function.

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.

The volunteers, that have been randomly assigned to the Test product arm of the study, will be administered one oral capsule/day of the Probiotic mix CBP-004019/C (Biopolis SL) during the intervention period (1 month). The product contains 1X10Exp9 cfu/capsule of the probiotic mix (Bifidobacterium lactis, Bifidobacterium longum, Lactobacilus casei and Lactobacillus rhamnosus) plus maltodextrin and sugar.

The volunteers that have been randomly assigned to this arm of the study will receive one oral capsule per day of the placebo product (Biopolis SL) during the 1 month intervention period. The product contains maltodextrin and sugar.

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 SIBO Diabetes 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