Lacticaseibacillus Rhamnosus GG Pili Study

Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Dietary supplement: Probiotic

Detailed Description

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
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Örebro, Sweden, 703 62
    • Örebro University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Wild-type; Supplementation with the wild-type of the LGG strain	Dietary supplement: Probiotic; Other Names: LGG
Experimental: Low-pill; Supplementation with the low-pili LGG strain	Dietary supplement: Probiotic; Other Names: LGG
Experimental: High-pili; Supplementation with the high-pili LGG strain	Dietary supplement: Probiotic; Other Names: LGG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6hrs supplementation after start of LGG strain administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	2 days after LGG strain administration
Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	7 days after LGG strain administration
Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	14 days after LGG strain administration

Collaborators and Investigators

• Sponsor: Örebro University, Sweden
• Collaborators: Chr Hansen; Valio Ltd
• Investigators: Study Director: Robert Brummer, Professor, Örebro University, School of Medical Sciences, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2016
• Primary Completion (Actual): June 30, 2017
• Study Completion (Actual): June 30, 2017

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: July 13, 2022
• First Posted (Actual): July 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 18, 2022
• Last Update Submitted That Met QC Criteria: July 13, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Probiotics; Gut microbiota; Transcriptomics; Small intestine; Lacticaseibacillus rhamnosus GG; Pili
• Other Study ID Numbers: 2015/422

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No