Physicians are currently finding products for pediatric respiratory diseases of viral etiology to reduce the inappropriate use of antibiotic therapy. This study evaluated PediaFlù (Pediatrica S.r.l.), a dietary supplement already on the market composed of honey, propolis, Pelargonium sidoides extract, and zinc (DSHPP), in children affected by acute tonsillopharyngitis (ATR). The open-label, randomized, and controlled study compared DSHPP + standard of care (SoC) versus SoC alone for six days. Children between 3 and 10 years with an ATR ≤ 48 h, a negative rapid test for beta-hemolytic Streptococcus, or a culture identification of nasal and/or pharyngeal exudates were included. A tonsillitis severity score (TSS) and the number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) were the primary endpoints. DSHPP+ SoC showed better performance than SoC alone for TSS sub-scores: throat pain and erythema on day 6 (p < 0.001 and p < 0.05), swallowing (p < 0.01 on day 4), and TSS total score on days 4 and 6 (p < 0.05 and p < 0.001). Only one patient (SoC group) had treatment failure for ibuprofen administration. No adverse events were reported. DSHPP is an optimal adjuvant in the treatment of URTI and could potentially be useful in the daily clinical practice of paediatricians evaluating the correct antibiotic prescription.

Background: A dietary supplement containing Pelargonium sidoides extract, propolis, zinc, and honey has been recently developed and proven to be an effective adjuvant in clinical practice for seasonal diseases and the treatment of respiratory tract disorders. Objective: This trial aims to verify the efficacy of the tested dietary supplement in a pediatric population with acute tonsillopharyngitis/rhinopharyngitis (ATR). Methods: The trial includes children aged between 3 and 10 years with ATR ≤48 h, a negative rapid test for beta-hemolytic streptococcus or culture identification of nasal and/or pharyngeal exudates, and SARS-CoV-2 infection. The dietary supplement tested is an oral solution already on the market based on Pelagon P-70 (equivalent to Pelargonium sidoides d.e. 133.3 mg/100 ml), propolis, zinc, and honey. The product is administered at 5 ml 3 times a day for 6 days for children younger than 6 years and 10 ml 3 times a day for 6 days for children older than 6 years. The study design is open label, randomized, and controlled, with the tested dietary supplement plus standard of care (SoC) versus SoC alone. Patients are enrolled from 3 sites in Romania. The change in Tonsillitis Severity Score and number of treatment failures (using ibuprofen or high-dose paracetamol as rescue medication) are the primary end points. Based on the Tonsillitis Severity Score and the 2-sample comparison of the means formula with a 5% significance level, 80% power, and a minimally clinically important difference of 2 (SD 3.85) points, 120 patients are required. To account for potential screening failures and dropouts, we need to screen a population of approximately 150 children. Results: Patient enrollment began on June 3, 2021 (first patient’s first visit), and ended on August 12, 2021 (last patient’s last visit). The data collection period was from June 3, 2021, to September 16, 2021. The study was funded in February 2023. Data analysis is currently ongoing (April 2024). We expect the results to be published in a peer-reviewed clinical journal in the third quarter of 2024 and presented at scientific meetings in the last quarter of 2024. Conclusions: The data from this trial may help identify new adjuvant treatments for children with ATR when streptococcal infection is excluded by a negative rapid test, thereby avoiding unnecessary antibiotic administration. Trial Registration: ClinicalTrials.gov NCT04899401 https://clinicaltrials.gov/study/NCT04899401 International Registered Report Identifier (IRRID): DERR1-10.2196/53703

Background: The medical literature has reported that recurrent bacterial vaginosis (RBV) has a relapse rate of 35% within 3 months and 60% within 12 months after antibiotic administration. Products that are able to provide a barrier effect against the biofilm produced by Gardnerella vaginalis could play a role in improving the results of bacterial vaginosis (BV) treatment. Objective: This study aims to assess the performance and safety of a medical device (Polybactum) containing polycarbophil, lauryl glucoside, and glycerides (PLGG) for reducing the rate of recurrence of BV. Methods: The study includes women who are aged above 18 years, are willing to provide signed informed consent, have a diagnosis of BV according to the Amsel criteria, and have been affected by at least 2 episodes of RBV in the last 12 months. The trial includes 2 phases. In the first phase (according to an open-label noncontrolled design), the treatment involving PLGG is administered for 3 cycles and is followed by a 1-month period of follow-up without treatment. In the second phase, a 9-month follow-up period is envisaged. Thus, for each patient, a 10-month follow-up period without treatment is planned. The study involves 5 centers (2 in Italy and 3 in Romania). We calculated a sample size of 44 pairs to achieve a power of 80% and a 1-sided significance of 5% for detecting a difference of 0.25 between marginal proportions, in comparison with the mean recurrence rate of BV reported in the medical literature. We estimated a potential dropout rate of 20%, and thus, we decided to enroll 55 patients (1-group chi-square test). Results: The study received ethics approval in 2016 in Romania and 1 year later in Italy. Recruitment started in September 2016. An interim analysis was performed in 2019, and full study analysis results are expected in July 2023. Conclusions: The tested medical device involving PLGG could modify the mechanisms involved in the pathogenesis of BV and could improve microbiological parameters owing to the acidifying effect on vaginal pH. We believe that the findings of our study could be useful for other investigators who want to test different products against RBV using a standardized protocol and standardized procedures. Trial Registration: ClinicalTrials.gov NCT02863536; https://clinicaltrials.gov/ct2/show/NCT02863536 International Registered Report Identifier (IRRID): RR1-10.2196/42787

Recurrent bacterial vaginosis (RBV) after antibiotic treatments has a relapse rate of 35% within 3 months and 60% within 12 months. Products containing polycarbophil (PLGG), that inhibits bacterial growth and mucoadhesive property, can impair biofilm formation. Here are shown the results of the POLARIS (Polybactum® to assess Recurrent Bacterial Vaginosis) study. The first phase was an interventional, open-label, non-controlled, and multicentre trial enrolling 56 women in Italy and Romania. The second phase was an observational 10-month follow-up without treatment conducted only in Romania. After 3 cycles with PLGG, only 8 BV recurrences out of 54 evaluable patients were identified (rate 14.81%) and for 26 out of 39 patients (66.67%) was evidenced positive effect on Lactobacilli in the vaginal secretions. In the follow-up 35 patients were observed after PLGG stopping treatment; 1 RBV (2.86%) at the 4th month and an additional 6 cases (17.14%) were evidenced at the end of the follow-up period. Therefore, no recurrence was evidenced in 12 subjects (34.28%) at 10th ± 2 months after the end of the PLGGtreatment. The use of PLGG vaginal ovules in the treatment of BV reduces the rate of relapses and improves the microbiological parameters (positive effect on Lactobacilli in 66.7 % of cases).

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