Lacticaseibacillus Rhamnosus GG Pili Study

Study Overview
=================
Brief Summary
-----------------
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

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.

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

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Probiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The individuals did receive the three treatment combinations in a randomised order.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Wild-type<br>Supplementation with the wild-type of the LGG strain | Dietary Supplement: Probiotic<br> <br> * Other names: LGG;|
| Experimental: Low-pill<br>Supplementation with the low-pili LGG strain | Dietary Supplement: Probiotic<br> <br> * Other names: LGG;|
| Experimental: High-pili<br>Supplementation with the high-pili LGG strain | Dietary Supplement: Probiotic<br> <br> * 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lacticaseibacillus rhamnosus GG, Probiotics, Pili, Gut microbiota, Transcriptomics, Small intestine