Healthy Response to Probiotics
Conditions
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.
Interventions
DIETARY_SUPPLEMENTLGG
LGG is dissolved in water and consumed at one occasion (either at visit 2 or 3)
DIETARY_SUPPLEMENTPlacebo
Placebo is dissolved in water and consumed at one occasion (either at visit 2 or 3)
Sponsors
University of Copenhagen
Herlev Hospital
Chr Hansen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy men or women 2. No medication 3. Age between 18 and 35 years 4. BMI below 30 5. Provided voluntary written informed consent
Exclusion criteria
1. All clinical diagnoses and disorders requiring medicine 2. Patient diagnosed with inflammatory bowel disease such as ulcerative colitis and Crohn's disease, colorectal cancer or suffering from irritable bowel syndrome. 3. Pregnant and women who are breast-feeding 4. Patient with known blood clothing disorders 5. Patients with clinical psychiatric diagnoses (including dementia) 6. Individuals who have undergone abdominal surgery, which might have effect on the GI function, except appendectomy and cholecystectomy 7. Individuals with high blood pressure (≥140 mmHg /90 mmHg) 8. Systemic use of antibiotics or steroids or antimicrobial medication in the last 4 months 9. Daily usage of NSAID in the last 2 months or incidental use in the last 2 weeks prior to screening 10. Usage of medications, except oral contraceptives, during the 14 days prior to screening 11. Lactose intolerance 12. Participation in other clinical trials in the past three months 13. Regular use of probiotics in the last 6 weeks 14. Smoking 15. Planned changes to current diet or exercise regime 16. Use of laxatives, anti-diarrheals, anti-cholinergics within last 4 weeks prior to screening 17. Use of immunosuppressant drugs within last 4 weeks prior to screening 18. Ulcer or malignancy in the intestine which is discovered during second visit
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Genome-wide gene expression | 3 years | The effect of LGG on genome-wide gene expression in intestinal tissue and cells |
Secondary
| Measure | Time frame |
|---|---|
| 16S analysis of luminal fluid | 3 years |
Countries
Denmark
Outcome results
None listed