Healthy Response to Probiotics Clinical Trial
Official title:
Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions
The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells
The study includes 3 visits. The first visit serves to check inclusion/exclusion
criteria/complete questionnaire/give information about the study and receive consent. At
visit 2 and 3 the included individuals will drink a placebo blend or a drink containing
Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper
intestine during endoscopy while under nurse administered propofol sedation (NAPS). There
will be four weeks between visit 2 and 3.
At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will
be collected, and one blood sample will be collected.
The down stream analysis will include a combination of gene expression analysis, microbiome
analysis and classification of the individuals based on analysis of blood samples.
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