Lacticaseibacillus Rhamnosus GG Pili Study

Örebro University, Sweden10 enrolled

Overview

The aim of this study was to investigate the host-microbe interaction effects of various Lacticaseibacillus rhamnosus GG strains, with different binding capacities to the mucus in the small intestine, in healthy individuals

The project consisted in the supplementation of a) a wild-type LGG strain, b) a low-producing pili LGG strain or c) a high-producing pili LGG strain to study subjects. The individuals received the three treatment combinations in a randomised order. Each supplementation was given to the individuals every 30 min over a period of 6 hours. Eight biopsies from the duodenum were collected at the end of 6 h-solutions administration by flexible gastroduodenoscopy, likewise the routine procedure during this endoscopic investigation. Faecal samples were collected by the study subjects at home 1 day before, 2, 7 and 14 days days after administrations of each oral supplementation. The supplementations were separated by a 3-week wash-out period.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Enrollment

Conditions

Healthy

Interventions

ProbioticDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy males or females aged 18-65 years. * Willing to abstain from any probiotics or medication known to alter gastrointestinal function during the study. * A signed informed consent. Exclusion Criteria: * Recent or current treatment with drugs affecting intestinal function, immune function or mood (e.g. antidepressants). In addition use of all drugs during the study should be recorded. * Recent (\< 6 weeks) use of probiotics\*. * Diagnosis of major psychiatric or somatic disorders. * Pregnancy or breastfeeding. * Abuse of alcohol or drugs. * Smokers and chewable tobacco users. * Lactose intolerance. * Any kind of probiotics and with special attention on products containing LGG: Dairy products: * Valio Kefir * Valio Gefilus yoghurt Dietary supplements: * Bifiform Daily * Bifiform Travel * Bifiform Daily Caps

Locations (1)

Örebro University

Örebro, Sweden

Outcomes

Primary Outcomes

Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain

Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain

Time frame: 6hrs supplementation after start of LGG strain administration.

Microbiome of duodenal mucosal biopsies

Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene

Time frame: 6hrs supplementation after start of LGG strain administration

Secondary Outcomes

Faecal microbiome

Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

Time frame: 2 days after LGG strain administration

Faecal microbiome

Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

Time frame: 7 days after LGG strain administration

Faecal microbiome

Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

Time frame: 14 days after LGG strain administration

Data from ClinicalTrials.gov

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