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| ID | Type | Description | Link |
|---|---|---|---|
| 200918 | Other Identifier | CRO |
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| Name | Class |
|---|---|
| NIZO Food Research | OTHER |
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Assess efficacy of oral ingestion of a probiotic product on immune function in a population of healthy adult men and women in a clinical vaccination study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental | 2B Colony Forming Unit/ day |
|
| Placebo | Placebo Comparator | Equivalent placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic effect on influenza vaccine response | Dietary Supplement | Seroconversion rate: the percentage of subjects achieving at least a 4-fold increase or an increase from >10 to 40 in Ab titre for seronegative subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rate | Percentage of subjects achieving at least a 4-fold increase or an increase from >10 to 40 in Antibody titer for seronegative subjects | From baseline to week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma cytokine levels | Change in plasma cytokine levels (IL-10, IL-4, TFN alpha, IFN gamma) | Baseline, week 2 and week 6 |
| Change in IgA antibodies against influenza | Titer of plasma anti-influenza IgA |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alwine Kardinaal, PhD | NIZO food research B.V | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alwine Kardinaal, PhD NIZO food research B.V | Ede | Netherlands |
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| ID | Term |
|---|---|
| D006679 | HIV Seropositivity |
| ID | Term |
|---|---|
| D015658 | HIV Infections |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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| baseline, week 2, week 6 |
| Change in IgG antibodies against influenza | Titer of plasma anti-influenza IgG | baseline, week 2, week 6 |
| Change in IgM antibodies against influenza | Titer of plasma anti-influenza IgM | baseline, week 2, week 6 |
| Change in Gastrointestinal symptoms | Gastrointestinal manifestations documented through Gastrointestinal Symptom Rating Scale (GSRS, 7-point graded Likert-type scale and includes 15 items combined into 5 symptom clusters - 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms) | baseline, week 2, week 6 |
| Change in Incidence of respiratory infections | Assessment of respiratory infection through questionnaire (4-point graded Likert-type scale and includes 11 items, including the 8 items comprising the Jackson common cold questionnaire - 0 = absent, 1 = mild, 2 = moderate, 3 = severe) | baseline, week 2, week 6 |
| D015229 |
| Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D016180 | Lentivirus Infections |
| D012192 | Retroviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |