Clinical trial NCT05461443: Lacticaseibacillus Rhamnosus GG Pili Study
Official title: Study of the Modularity Immune Function of Lactobacillus Rhamnosus GG in the Small Intestine of Healthy Individuals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Lacticaseibacillus rhamnosus GG
Probiotics
Pili
Gut microbiota
Transcriptomics
Small intestine
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
Collaborators: name: Valio Ltd
name: Chr Hansen
First posted: 2022-07-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The individuals did receive the three treatment combinations in a randomised order.
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain
timeFrame: 6hrs supplementation after start of LGG strain administration.
measure: Microbiome of duodenal mucosal biopsies
timeFrame: 6hrs supplementation after start of LGG strain administration
Secondary outcomes:
measure: Faecal microbiome
timeFrame: 2 days after LGG strain administration
measure: Faecal microbiome
timeFrame: 7 days after LGG strain administration
measure: Faecal microbiome
timeFrame: 14 days after LGG strain administration
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University
Study officials:
affiliation: Örebro University, School of Medical Sciences, Sweden
name: Robert Brummer, Professor
role: STUDY_DIRECTOR
References: