Gastrointestinal Symptoms, Gut Microbiota
Conditions
Keywords
Human milk oligosaccharides, Microbiota, Prebiotics
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTHMO
DIETARY_SUPPLEMENTGlucose
Sponsors
Glycom A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed written informed consent * Ability and willingness to understand and comply to the study procedures
Exclusion criteria
* Participation in a clinical study one month prior to screening visit and throughout the study. * Abnormal results of the screening laboratory tests clinically relevant for study participation, as judged by the investigator. * Any gastrointestinal symptom scored \>3 on the GSRS during the screening period * A mean score on the total GSRS \>2 (i.e. above the population norm value) during the screening period * Any gastrointestinal disease(s) that may cause symptoms or may interfere with the trial outcome, as judged by the investigator. * Other severe disease(s) such as malignancy, diabetes, severe coronary disease, kidney disease or neurological disease, as judged by the investigator. * Severe psychiatric disease, as judged by the investigator. * Use of highly dosed probiotic supplements (yoghurt allowed) 3 months prior to the study and throughout the study. * Consumption of antibiotic drugs 3 months prior to screening and throughout the study. * Consumption on a regular basis of medication that might interfere with symptom evaluation (as judged by the investigator) 2 weeks prior to screening and throughout the study. * Pregnant or lactating or wish to become pregnant during the period of the study. * Lack of suitability for participation in the study for any reason as judged by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of study product in urine | 0 and 6 hours post intake | Detectability of study product in urine 6 hours post intake |
| Change from baseline in faecal microbiota | Baseline and after 2 weeks of intake | Change from baseline in microbiota after 2 weeks of intake |
| Change from baseline in gastrointestinal symptoms measured with the Gastrointestinal Symptom Rating Scale (GSRS) | Baseline and after 2 weeks of intake | Change from baseline in GSRS after 2 weeks of intake |
| Plasma concentration of study product | 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. |
| Change from baseline in Bristol Stool form (BSF) scale | Baseline and during intake. Registered daily during study period. | Change from baseline in BSF during intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in clinical chemistry | Baseline and after 2 weeks of intake | Change from baseline in clinical chemistry after two weeks of intake. |
| Change in specific biomarkers in serum | Baseline and after 2 weeks of intake | Change from baseline in specific biomarkers in serum after two weeks of intake |
| Number of participants with adverse events | Baseline to end of the 2 weeks of intake | Registration of adverse events during intake of study product. |
| Change in specific biomarkers in faeces | Baseline and after 2 weeks of intake | Change from baseline in specific biomarkers in faeces after 2 weeks of intake |
| Change in haematology | At baseline and after 2 weeks of intake | Change from baseline in haematology after 2 weeks of intake |
Countries
Denmark
Outcome results
None listed