Trial · NCT07908797
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of clinically confirmed upper respiratory tract infection (URTI) episodes per participant | 16 weeks (Week 0 to Week 16) | The number of clinically confirmed URTI episodes experienced by each participant during the study. |
| Secondary | Proportion of participants experiencing clinically confirmed URTI episodes | 16 weeks (Week 0 to Week 16) | Proportion of participants experiencing at least 1, at least 2, and at least 3 clinically confirmed URTI episodes during the study period. |
| Secondary | URTI episode duration and timing | 16 weeks (Week 0 to Week 16) | Duration of individual clinically confirmed URTI episodes, cumulative symptomatic days, URTI-free time, and time to first clinically confirmed URTI episode. |
| Secondary | Predominant symptom-based URTI clinical presentation | 16 weeks (Week 0 to Week 16) | Clinical characteristics and treatment outcomes of clinician-confirmed URTI episodes classified according to the prespecified study-specific symptom-domain classification. |
| Secondary | Sore-throat outcomes during clinically confirmed URTI episodes | 16 weeks (Week 0 to Week 16) | Number of clinically confirmed URTI episodes involving sore throat, duration and severity. |
| Secondary | Medication and healthcare utilisation related to URTI episodes | 16 weeks (Week 0 to Week 16) | Use of symptomatic medications, prescribed antibiotics, and healthcare services related to clinically confirmed URTI episodes. |
| Secondary | Days absent from work or study due to URTI illness | 16 weeks (Week 0 to Week 16) | Number of days absent from work or study because of clinically confirmed URTI illness during the study period. |
| Secondary | Health-related quality of life | Baseline (Week 0), Week 12, and Week 16 | Health-related quality of life assessed using the EQ-5D-5L at prespecified study timepoints. |
| Secondary | Gastrointestinal symptoms | Baseline (Week 0), Week 12, and Week 16 | Gastrointestinal symptom burden assessed using the 15-item Gastrointestinal Symptom Rating Scale (GSRS). |
| Secondary | Change in oral microbiota composition | Baseline (Week 0) to Week 12 | Changes in oral microbiota composition and prespecified microbiota features assessed using 16S rRNA gene sequencing of saliva samples collected at baseline and Week 12. |
| Secondary | Change in systemic inflammatory biomarkers | Baseline (Week 0) to Week 12 | Changes in systemic inflammatory biomarkers, including high-sensitivity C-reactive protein (hs-CRP) and interleukin-6 (IL-6), assessed using fasting blood samples collected at baseline and Week 12. |
| Secondary | Adherence to the study intervention | 12 weeks (Week 0 to Week 12) | Adherence to the allocated study product assessed during the 12-week intervention using electronic adherence records and corroborated by returned sachet counts at Week 12. |
| Secondary | Safety and tolerability | 16 weeks (Week 0 to Week 16) | Frequency, nature, severity, seriousness, and relationship to the study product of reported adverse events, together with study-product discontinuations attributable to adverse events. |
| Secondary | Dietary intake and physical activity | Baseline (Week 0), Week 12, and Week 16 | Dietary intake and prespecified measures of physical activity, including changes where applicable, assessed over the study period. |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this list from software.
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GET https://conductscience.org/api/trials/v1/NCT07908797/registered