The study is a randomised, placebo-controlled, double-blind, parallel, dose-finding study with healthy volunteers. A total of 100 male and female volunteers will be included. The volunteers will be randomized into one of 10 groups, each of 10 participants, consuming either active product in various mixes and doses (9 groups) or placebo product (1 group) for 2 weeks. The 9 groups receiving active product will receive either one of two Human Milk Oligosaccharides (HMOs) alone or in combination at different doses. The primary purpose of the study is establishing the effects of various compositions and doses of HMOs on the faecal flora and on gastrointestinal symptoms in health adults.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Enrollment
100
Department of Medicine, Køge Hospital
Køge, Denmark
Change from baseline in faecal microbiota
Change from baseline in microbiota after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS)
Change from baseline in GSRS after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Plasma concentration of study product
Detectability of study product in plasma at 0, 3, 6 and 9 hours post intake.
Time frame: 0, 3, 6, and 9 hours post intake of study product.
Change from baseline in Bristol Stool form (BSF) scale
Change from baseline in BSF during intake
Time frame: Baseline and during intake. Registered daily during study period.
Concentration of study product in urine
Detectability of study product in urine 6 hours post intake
Time frame: 0 and 6 hours post intake
Change in specific biomarkers in serum
Change from baseline in specific biomarkers in serum after two weeks of intake
Time frame: Baseline and after 2 weeks of intake
Number of participants with adverse events
Registration of adverse events during intake of study product.
Time frame: Baseline to end of the 2 weeks of intake
Change in clinical chemistry
Change from baseline in clinical chemistry after two weeks of intake.
Time frame: Baseline and after 2 weeks of intake
Change in specific biomarkers in faeces
Change from baseline in specific biomarkers in faeces after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Change in haematology
Change from baseline in haematology after 2 weeks of intake
Time frame: At baseline and after 2 weeks of intake
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