Department of Medicine, Køge Hospital
Køge, 4600, Denmark
NCT Number: NCT01927900
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.
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Notify Me18 year–60 year
All sexes
Interventional
Not applicable
Køge, 4600, Denmark
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Baseline and after 2 weeks of intake
Change from baseline in microbiota after 2 weeks of intake
Time frame: Baseline and after 2 weeks of intake
Change from baseline in GSRS after 2 weeks of intake
Time frame: 0, 3, 6, and 9 hours post intake of study product.
Detectability of study product in plasma at 0, 3, 6 and 9 hours post intake.
Time frame: Baseline and during intake. Registered daily during study period.
Change from baseline in BSF during intake
Time frame: 0 and 6 hours post intake
Detectability of study product in urine 6 hours post intake
Time frame: Baseline and after 2 weeks of intake
Change from baseline in specific biomarkers in serum after two weeks of intake
Time frame: Baseline to end of the 2 weeks of intake
Registration of adverse events during intake of study product.
Time frame: Baseline and after 2 weeks of intake
Change from baseline in clinical chemistry after two weeks of intake.
Time frame: Baseline and after 2 weeks of intake
Change from baseline in specific biomarkers in faeces after 2 weeks of intake
Time frame: At baseline and after 2 weeks of intake
Change from baseline in haematology after 2 weeks of intake
Glycom A/S
Industry
THE EFFECTS OF HUMAN-MILK-OLIGOSACCHARIDES ON THE FAECAL MICROBIOTA AND ON GASTROINTESTINAL SYMPTOMS IN HEALTHY VOLUNTEERS A PARALLEL, DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED DOSE FINDING STUDY
Acronym: HMO-VOL
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.
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