NCT02928484

Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

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

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Biopolis S.L. · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• Signs and Symptoms, Digestive
• Dyspepsia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic mix CBP-004019/C	One capsule per day of the probiotic mix CBP-004019/C during one month.
DIETARY_SUPPLEMENT	Placebo	One capsule per day of the placebo (maltodextrin) during one month.

Timeline

• Start date: 2016-06-01
• Primary completion: 2017-06-01
• Completion: 2017-12-01
• First posted: 2016-10-10
• Last updated: 2016-10-10

Locations

1 site across 1 country: Spain