Healthy
Conditions
Keywords
Lacticaseibacillus rhamnosus GG, Probiotics, Pili, Gut microbiota, Transcriptomics, Small intestine
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.
Interventions
DIETARY_SUPPLEMENTProbiotic
Sponsors
Valio Ltd
Chr Hansen
Örebro University, Sweden
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
The sachets containing the different LGG strains were labelled as A, B, and C. The codes for each strain were kept by the industrial partner that provided the probiotic strains. Only at the end of the data analyses were the codes disclosed
Intervention model description
The individuals did receive the three treatment combinations in a randomised order.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain | 6hrs supplementation after start of LGG strain administration. | Microarray-based Gene expression Analysis were carried out from duodenal biopsies collected after the supplementation of each LGG strain |
| Microbiome of duodenal mucosal biopsies | 6hrs supplementation after start of LGG strain administration | Bacterial composition was analysed by Illumina MiSeq sequencing the hypervariable V3-V4 region of the 16S rRNA gene |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Faecal microbiome | 2 days after LGG strain administration | Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene |
Countries
Sweden
Outcome results
None listed