Gastro Intestinal Infection Clinical Trial
Official title:
The Effects of Oral Administration of Lactobacillus Plantarum WCFS1, Lactobacillus Plantarum CIP104448, and Lactobacillus Plantarum CIP104450 on Small Intestinal Mucosa and Barrier Function
The design of this study conforms to a randomized double-blind placebo-controlled cross-over
design.
The objective of the study is to assess the effect of three probiotics (Lactobacillus
plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450)
on intestinal epithelial permeability and the immune system, in at least 8 healthy subject.
The effect of the three different probiotics and a placebo will be assessed on every subject
in random sequence.
Prior to the start of a 7-days supplementation period (one of the three probiotic
supplements or placebo), blood samples will be obtained and small intestinal permeability
will be assessed by measuring the urinary extraction ratios of ingested water-soluble,
non-degradable test probes, with and without indomethacin challenge (to compromise the gut).
After each supplementation period the gut will be stressed again by the indomethacin
protocol, followed by measurement of small intestinal permeability, whereupon blood samples
will be taken and duodenal tissue samples will be obtained by standard gastroduodenoscopy.
Each supplementation period will start 1 month after finishing the pervious test episode, in
randomized sequence.
The primary objective of this study is to assess the effects of Lactobacillus plantarum
WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450 on
intestinal epithelial permeability. Secondary objectives are to assess the effects on immune
modulation, gene expression of peripheral blood mononuclear cells, small intestine
epithelial gene regulation and tight junction proteins modulation, infiltration of immune
cells in intestinal mucosa and immune markers in blood plasma.
The investigators hypothesize that Lactobacillus plantarum WCFS1, Lactobacillus plantarum
CIP104448, and Lactobacillus plantarum CIP104450 will, each separately, significantly affect
the innate immune system and intestinal permeability in humans.
n/a
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention