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Effects of Administration of L.Plantarum WCFS1, L.Plantarum CIP104448, L.Plantarum CIP104450 on Small Intestinal Mucosa

NCT01456767 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2012-07-19

No results posted yet for this study

Summary

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.

Conditions

  • Gastro Intestinal Infection

Interventions

DIETARY_SUPPLEMENT

Probiotics

Bacterial supplements (Lactobacillus plantarum WCFS1, Lactobacillus plantarum CIP104448, and Lactobacillus plantarum CIP104450) will be prepared in the food-grade pilot plant of NIZO food research. Exactly 1x10\^11 life bacteria are consumed by each participant. Consumption of this amount of life bacteria is in line with earlier human studies and routinely reached by the consumption of dairy. As a placebo, the same drink will be used without addition of bacterial cells.

Sponsors & Collaborators

  • Maastricht University Medical Center

    lead OTHER

Principal Investigators

  • Ad Masclee, Prof. dr. · Maastricht University Medical Center

  • Freddy Troost, Dr. · Maastricht University Medical Center

  • Zlatan Mujagic · Maastricht University Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-04-30

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01456767 on ClinicalTrials.gov