Clinical Trial: Evaluation of the Effect of a Probiotic Supplement Upon Gastrointestinal Function

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

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

Detailed Summary: 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.
Sponsor: Biopolis S.L.

Current Primary Outcome: Functional dyspepsia symptoms [ Time Frame: 3 months ]

Physician determined symptoms according to Rome III criteria.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Relative proportions of the main microbial groups of the intestinal microbiota [ Time Frame: 3 months ]
    Global profile of intestinal microbiota composition established by 16S rRNA profiling
  • Dyspepsia associated quality of life [ Time Frame: 3 months ]
    Questionaires for symptoms and QoL associated to dyspepsia and for anxiety/depression
  • Serum IFN-gamma levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of IFN-gamma
  • Serum TNF-alpha levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of TNF-alpha
  • Serum IL-12 levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of IL-12
  • Serum IL-4 levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of IL-4
  • Serum IL-10 levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of IL-10
  • Serum TGF-beta levels [ Time Frame: 3 months ]
    Determination of the serum concentration (pg/mL) of TGF-beta
  • Fecal levels of Bifidobacterium [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Bifidobacterium in fecal samples by qPCR
  • Fecal levels of Lactobacillus [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Lactobacillus in fecal samples by qPCR
  • Fecal levels of Bacteroides [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Bacteroides in fecal samples by qPCR
  • Fecal levels of Blautia [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Blautia in fecal samples by qPCR
  • Fecal levels of Akkermansia [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Akkermansia in fecal samples by qPCR
  • Fecal levels of Faecalibacterium [ Time Frame: 3 months ]
    Determination of the levels (log cells/gr) of Faecalibacterium in fecal samples by qPCR


Original Secondary Outcome: Same as current

Information By: Biopolis S.L.

Dates:
Date Received: September 7, 2016
Date Started: June 2016
Date Completion: December 2017
Last Updated: October 7, 2016
Last Verified: October 2016