Lacticaseibacillus Rhamnosus GG Pili Study

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05461443
• Other study ID #: 2015/422
• Status: Completed
• Phase: N/A
• Start date: March 31, 2016
• Est. completion date: June 30, 2017

Study information

• Verified date: July 2022
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: June 30, 2017
• Est. primary completion date: June 30, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Probiotic

Locations

Country	Name	City	State
Sweden	Örebro University	Örebro

Sponsors (3)

Lead Sponsor	Collaborator
Örebro University, Sweden	Chr Hansen, Valio Ltd

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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	Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	2 days after LGG strain administration
Secondary	Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	7 days after LGG strain administration
Secondary	Faecal microbiome	Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene	14 days after LGG strain administration