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| ID | Type | Description | Link |
|---|---|---|---|
| SJ-345 | Other Identifier | The Scientific Ethical Comitee of Regional Zealand |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMO1 | Active Comparator | HMO diluted in water |
|
| Glucose | Placebo Comparator | Glucose diluted in water |
|
| HMO2 | Active Comparator | HMO diluted in water |
|
| HMO3 | Active Comparator | HMO diluted in water |
|
| HMO4 | Active Comparator | HMO diluted in water |
|
| HMO5 | Active Comparator | HMO diluted in water |
|
| HMO6 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HMO | Dietary Supplement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in faecal microbiota | Change from baseline in microbiota after 2 weeks of intake | 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 | 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. | 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 | 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 | 0 and 6 hours post intake |
| Measure | Description | Time Frame |
|---|---|---|
| Change in specific biomarkers in serum | Change from baseline in specific biomarkers in serum after two weeks of intake | Baseline and after 2 weeks of intake |
| Number of participants with adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Bytzer, MD | Department of Medicine, Køge Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Medicine, Køge Hospital | Køge | 4600 | Denmark |
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| ID | Term |
|---|---|
| D006279 | Health Maintenance Organizations |
| D005947 | Glucose |
| ID | Term |
|---|---|
| D008329 | Managed Care Programs |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D005381 | Financing, Organized |
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| Active Comparator |
HMO diluted in water |
|
| HMO7 | Active Comparator | HMO diluted in water |
|
| HMO8 | Active Comparator | HMO diluted in water |
|
| HMO9 | Active Comparator | HMO diluted in water |
|
| Glucose | Dietary Supplement |
|
Registration of adverse events during intake of study product.
| Baseline to end of the 2 weeks of intake |
| Change in clinical chemistry | Change from baseline in clinical chemistry after two weeks of intake. | 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 | Baseline and after 2 weeks of intake |
| Change in haematology | Change from baseline in haematology after 2 weeks of intake | At baseline and after 2 weeks of intake |
| D004467 |
| Economics |
| D004472 | Health Care Economics and Organizations |
| D017061 | Prepaid Health Plans |
| D006123 | Group Practice |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |