Defining the Normal Human Response to Probiotics

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy Response to Probiotics

Intervention / Treatment
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* Dietary Supplement: LGG
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LGG<br>Lactobacillus rhamnosous (LGG) 450 billion CFU dissolved in water | Dietary Supplement: LGG<br>* LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)<br>|
| Placebo Comparator: Placebo<br>The placebo product is the same vegetable capsule as the experimental product, identical in composition, taste and appearance but without probiotics | Dietary Supplement: Placebo<br>* Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome-wide gene expression | The effect of LGG on genome-wide gene expression in intestinal tissue and cells | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 16S analysis of luminal fluid |  | 3 years |