Defining the Normal Human Response to Probiotics and Developing an in Vitro System to Identify New Microbes With Probiotic Functions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Genome-wide gene expression
Study Overview
Brief Summary
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
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 35 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Placebo
The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics
Intervention: Placebo (Dietary Supplement)
LGG
Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water
Intervention: LGG (Dietary Supplement)
Outcomes
Primary Outcomes
Genome-wide gene expression
Time Frame: 3 years
The effect of LGG on genome-wide gene expression in intestinal tissue and cells
Secondary Outcomes
- 16S analysis of luminal fluid(3 years)