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OpenTrials
Completed

NCT Number: NCT03140878

Defining the Normal Human Response to Probiotics

The study is a mono-center, randomized, semi-blinded, placebo-controlled, cross-over, proof-of principle study in healthy volunteers. The study will determine the probiotic effect of LGG on intestinal tissue and intestinal cells

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Key information

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Herlev hospital

Copenhagen, Denmark

About this study

The study includes 3 visits. The first visit serves to check inclusion/exclusion criteria/complete questionnaire/give information about the study and receive consent. At visit 2 and 3 the included individuals will drink a placebo blend or a drink containing Lactobacillus rhamnosus GG (LGG®) and they will subsequently be biopsied from the upper intestine during endoscopy while under nurse administered propofol sedation (NAPS). There will be four weeks between visit 2 and 3.

At visit 2 and 3, biopsies will be taken from duodenum and jejunum, and luminal fluids will be collected, and one blood sample will be collected.

The down stream analysis will include a combination of gene expression analysis, microbiome analysis and classification of the individuals based on analysis of blood samples.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy men or women
  • No medication
  • Age between 18 and 35 years
  • BMI below 30
  • Provided voluntary written informed consent

Exclusion criteria

  • All clinical diagnoses and disorders requiring medicine
  • Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome.
  • Pregnant and women who are breast-feeding
  • Patient with known blood clothing disorders
  • Patients with clinical psychiatric diagnoses (including dementia)
  • Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy
  • Individuals with high blood pressure (≥140 mmHg /90 mmHg)
  • Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months
  • Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening
  • Usage of medications, except oral contraceptives, during the 14 days prior to screening
  • Lactose intolerance
  • Participation in other clinical trials in the past three months
  • Regular use of probiotics in the last 6 weeks
  • Smoking
  • Planned changes to current diet or exercise regime
  • Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening
  • Use of immunosuppressant drugs within last 4 weeks prior to screening
  • Ulcer or malignancy in the intestine which is discovered during second visit

Treatment and study plan

LGG

Dietary Supplement

LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Placebo

Dietary Supplement

Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)

Primary outcomes

  1. Genome-wide gene expression

    Time frame: 3 years

    The effect of LGG on genome-wide gene expression in intestinal tissue and cells

Secondary outcomes

  1. 16S analysis of luminal fluid

    Time frame: 3 years

Sponsors and collaborators

Lead sponsor

Chr Hansen

Industry

Collaborators

  • Herlev Hospital
  • University of Copenhagen

Registry information

Official study title

Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
May 4, 2017
Registry last updated
Apr 23, 2018

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.