NCT03140878

Defining the Normal Human Response to Probiotics

Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Chr Hansen · Industry
• Sex: All
• Age: 18 Years – 35 Years
• Healthy volunteers: Accepted

Summary

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

Detailed description

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.

Conditions

• Healthy Response to Probiotics

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	LGG	LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)
DIETARY_SUPPLEMENT	Placebo	Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Timeline

• Start date: 2017-04-16
• Primary completion: 2017-06-11
• Completion: 2017-06-11
• First posted: 2017-05-04
• Last updated: 2018-04-23

Locations

1 site across 1 country: Denmark