The Effects of Bio Gelee Royale Forte on Immune Health in Healthy Adults
NCT Number: NCT06573814
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE2
Conditions: Upper Respiratory Tract Infection|URTI
Interventions: DIETARY_SUPPLEMENT: Bio Gelee Royale Forte|OTHER: Placebo
Sponsor: Medex d.o.o.
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 100
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-10
Completion Date: 2025-04

Summary:
The objective of this study is to evaluate the safety and efficacy of Bio Gelee Royale Forte compared to placebo on frequency, severity, and duration of upper respiratory tract infections (URTIs) among adults who are otherwise healthy but susceptible to URTIs during cold and flu season. Additionally, the safety and tolerability of Bio Gelee Royale Forte, as compared to placebo, will be measured by the occurrence of and/or changes in treatment emergent adverse effects.

Primary Outcome Measures: The difference in frequency, severity, and duration of upper respiratory tract infections (URTI)., The difference in frequency, severity, and duration of URTIs as assessed by the Wisconsin Upper Respiratory Symptom Survey-24 (WURSS-24) questionnaire over the 84-day supplementation period between Bio Gelee Royale Forte and Placebo. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome., Day -14 to day 84
Secondary Outcome Measures: The difference in frequency of URTIs from day -14 to day -1., The difference in frequency of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire, will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day -1|The difference in frequency of URTIs from day -14 to day 84., The difference in frequency of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|The difference in severity of URTI symptoms from day -14 to day -1., The difference in severity of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire and determined by the average severity scores of URTI symptoms will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day -1|The difference in severity of URTI symptoms from day -14 to day -1., The difference in severity of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire and determined by the area under the curve (AUC) for daily total symptom scores will be compared between Bio Gelee Royale Forte and Placebo. Area under the curve (AUC) for URTI symptoms from WURSS-24 is calculated daily from day -14 to day -1., day -14 to day -1|The difference in severity of URTI symptoms from day -14 to day 84., The difference in severity of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire and determined by the average severity scores of URTI symptoms will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|The difference in severity of URTI symptoms from day -14 to day 84., The difference in severity of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire and determined by the area under the curve (AUC) for daily total symptom scores will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|The difference in duration of URTI symptoms from day -14 to day -1., The difference in duration of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|The difference in duration of URTI symptoms from day -14 to day 84., The difference in duration of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|Severity of URTI symptoms over the 84-day supplementation period., Severity of URTI symptoms over the 84-day supplementation period as determined by the average severity score of URTI symptoms. The average severity score of each symptom is scored on scale of 0- no symptom to 7-severe symptom. A higher score would indicate worse outcome., baseline to day 84|The difference in proportion of participants with incidence of URTIs from day -14 to day -1., The difference in proportion of participants with incidence of URTIs from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day -1|The difference in proportion of participants with incidence of URTIs from baseline to day 84., The difference in proportion of participants with incidence of URTIs from baseline to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., baseline to day 84|The difference in proportion of participants with incidence of URTIs from day -14 to day 84., The difference in proportion of participants with incidence of URTIs from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to 84|The difference in number of sick days from day -14 to day -1., The difference in number of sick days from day -14 to day -1 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day -1|The difference in number of sick days from baseline to day 84., The difference in number of sick days from baseline to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., baseline to day 84|The difference in number of sick days from day -14 to day 84., The difference in number of sick days from day -14 to day 84 as assessed by the WURSS-24 questionnaire will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84|Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1., Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day -1 will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day -1|Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84., Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between baseline to day 84 will be compared between Bio Gelee Royale Forte and Placebo., baseline to day 84|Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84., Use of prescription and non-prescription cold/flu medications to treat URTI symptoms between day -14 to day 84 will be compared between Bio Gelee Royale Forte and Placebo., day -14 to day 84
Other Outcome Measures: Incidence of post-emergent adverse effects between day -14 to day 84., Incidence of post-emergent adverse effects between day -14 to day 84., day -14 to day 84