Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Onorach Clinical | UNKNOWN |
| CPS Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic strain | Dietary Supplement | Lactobacillus |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of URTI | The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of URTI with pathogens | The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, for which a pathogen is identified in nasal swabs, adjusted for sample size. | 16 weeks |
| The Number of days with URTI symptoms |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Gordon Crawford, DRCOG | CPS Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CPS Research | Glasgow | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34895109 | Derived | Damholt A, Keller MK, Baranowski K, Brown B, Wichmann A, Melsaether C, Eskesen D, Westphal V, Arltoft D, Habicht A, Gao Q, Crawford G. Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial. Benef Microbes. 2022 Feb 28;13(1):13-23. doi: 10.3920/BM2021.0065. Epub 2021 Dec 13. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dietary Supplement |
Placebo |
|
The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size. |
| 16 weeks |
| The number of days with temperature ≥ 38 °C | The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size. | 16 weeks |
| WURSS-K score | The Area under Curve for daily Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) score (range: not sick - very sick) during an URTI episode, which was diagnosed by a GP, adjusted for sample size. | 16 weeks |
| The number of subjects with one or more episode of URTI | The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size. | 16 weeks |
| The number of days of absence from daycare or primary school | The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size. | 16 weeks |