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| ID | Type | Description | Link |
|---|---|---|---|
| AFCRO158 | Other Identifier | Atlantia Food Clinical Trials |
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| Name | Class |
|---|---|
| Atlantia Food Clinical Trials | INDUSTRY |
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This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Experimental | Arm receiving investigational product (probiotic) |
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| Placebo | Placebo Comparator | Arm receiving placebo |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | Single strain probiotic in the form of a sachet with a daily dose of 3E+9 Colony Forming Unit (CFU) per day for 26 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI) | Presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline | Entire follow up period (total of 180 days) |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI | The presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 |
| Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal Microbiome analysis | Shallow shotgun metagenomic sequencing for 20% of cohort | Day 0, Day 180 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atlantia Food Clinical Trials | Cork | T23 R50R | Ireland |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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study consists of 2 arms, intervention and placebo.
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| Placebo | Dietary Supplement | Matching placebo in the form of a sachet once daily for 26 weeks |
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Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline |
| Day 0, Day 90, Day 180 |
| Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants | Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 |
| Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 |
| Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 |
| Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL) | Measured via saliva sample | Day 0, Day 180 |
| Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections | Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline | Day 0, Day 90, Day 180 |
| D019602 |
| Food and Beverages |