Lacticaseibacillus Rhamnosus GG Pili Study

NCT05461443 | Completed

• 1 other identifier: 2015/422
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Conditions

Healthy

Keywords

Lacticaseibacillus rhamnosus GG; Probiotics; Pili; Gut microbiota; Transcriptomics; Small intestine

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Faecal microbiome

  2 days after LGG strain administration

• Faecal microbiome

  7 days after LGG strain administration

• Faecal microbiome

  14 days after LGG strain administration

Study Arms (3)

Wild-type

ACTIVE COMPARATOR

Supplementation with the wild-type of the LGG strain

Dietary Supplement: Probiotic

Low-pill

EXPERIMENTAL

Supplementation with the low-pili LGG strain

Dietary Supplement: Probiotic

High-pili

EXPERIMENTAL

Supplementation with the high-pili LGG strain

Dietary Supplement: Probiotic

Interventions

Probiotic DIETARY_SUPPLEMENT

Also known as: LGG

High-pili; Low-pill; Wild-type

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Örebro University, Sweden: lead
• Valio Ltd: collaborator
• Chr Hansen: collaborator

Study Sites (1)

Örebro University

Örebro, 703 62, Sweden

Location

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Robert Brummer, Professor

  Örebro University, School of Medical Sciences, Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The individuals did receive the three treatment combinations in a randomised order.

Study Record Dates

• First Submitted: July 8, 2022
• First Posted: July 18, 2022
• Study Start: March 31, 2016
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: July 18, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)