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Completed

NCT Number: NCT05461443

Lacticaseibacillus Rhamnosus GG Pili Study

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

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University

Örebro, 703 62, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic

Dietary Supplement

Other names: LGG

Primary outcomes

  1. Difference in whole genome gene expression of duodenal mucosa after administration of three different LGG strain

    Time frame: 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

  2. Microbiome of duodenal mucosal biopsies

    Time frame: 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 outcomes

  1. Faecal microbiome

    Time frame: 2 days after LGG strain administration

    Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

  2. Faecal microbiome

    Time frame: 7 days after LGG strain administration

    Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

  3. Faecal microbiome

    Time frame: 14 days after LGG strain administration

    Bacterial composition by MiSeq sequencing hypervariable V3-V4 region of 16SrRNA gene

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Collaborators

  • Chr Hansen
  • Valio Ltd

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jul 18, 2022
Registry last updated
Jul 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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