Probiotic lozenges improve allergic rhinitis symptoms

Probiotic lozenges relieved symptoms of allergic rhinitis for at least a week after the end of treatment with minimal or no side effects during a single-center, 21-day interventional study, according to a press release.

The AllerPops (AllerPops Corp.) lozenges use multiple sugars and the amino acid L-Arginine, 5.04%, to provide balanced nutritional support to the oral microbiota and mitigate the nasal symptoms of allergy, according to the company.

“Probiotics, or the good bacteria in our mouth, pacify or calm down our immune system,” Cliff Han, PhD, inventor of AllerPops and founder of the company, told Healio.

The multiple sugars and amino acids in AllerPops promote the growth of Streptococcus and Veillonella, which have a symbiotic relationship, Han continued.

Cliff Han

“In the symbiosis, Streptococcus uses sugar to produce lactic acid and Veillonella takes lactic acid and produces short-chain fatty acids [SCFAs],” Han said. “SCFAs are not only less acidic but also interact with different immune cells to calm down inflammation.”

The lasting effect that SCFAs have on inflammation only can be achieved through continued production of SCFAs by local live bacteria, Han said.

The study involved 72 patients aged 18 to 70 years (23 men; average age, 37.8 years) with a clinical diagnosis of intermittent or persistent allergic rhinitis.

During the study, the 36-person investigational group cleaned their mouths before letting an AllerPop lozenge dissolve in their mouth over the course of 1 hour. Meanwhile, the members of a 36-person control group swallowed lozenges without cleaning their mouths or letting them dissolve.

Participants consumed one lozenge every other day at least three times or until they were satisfied with symptom relief through day 13.

According to unpublished study data the company provided to Healio, the investigational and control groups both experienced improvements in their individual and overall total nasal symptoms score (TNSS) at days 7, 14 and 21, although the differences between these groups were only statistically significant in the overall score (P = .016) and nasal sub-score (P = .032) on day 14.

Specifically, the investigational group experienced a 1.1 point decrease in overall TNSS scores by day 14 (P = .002), with significant changes in the runny nose (P = .022) and itching/sneezing (P = .002) sub-scores. The control group experienced significant improvements in its overall and all three sub-scores as well (P < .00001 for all).

Both groups also experienced improvements in their peak nasal inspiratory flow (PNIF) scores, although the only statistically significant differences between the groups occurred at day 14 (P = .045). Additionally, the control group experienced a significant change in PNIF values from baseline (P = .00002), but the investigational group did not.

IgE counts increased by day 7 and day 21 in the investigational group compared with baseline, the researchers continued, although they did not call these changes significant compared with the control group, where these counts only increased initially.

Both groups further experienced increases in eosinophils by day 7 and decreases by day 21 compared with baseline. The researchers did not consider the differences in these counts between the groups to be statistically significant.

Overall, the researchers said that the changes in IgE and eosinophils throughout the period were not statistically significant either.

“The participants would have gotten more relief had the regulatory agency allowed modulation of oral hygiene in the trial,” said Han, who theorizes that excessive oral hygiene and antibiotic usage contribute most to the current allergy epidemic.

With 16 adverse events in the control group and 26 in the investigational group, none of which were considered severe or moderate, the researchers said that treatment in both groups had an acceptable safety profile.

Regardless of whether patients consumed AllerPops slowly or quickly, the researchers said that they were safe and effective in treating the symptoms of allergic rhinitis and in improving airflow in the nasal airway.

Reference:

• Phase II clinical trial confirms safety and effectiveness of AllerPops. https://prnmedia.prnewswire.com/news-releases/phase-ii-clinical-trial-confirms-safety-and-effectiveness-of-allerpops-301660304.html. Published Oct. 27, 2022. Accessed Oct. 27, 2022.

For more information:

Cliff Han can be reached at cliffhan@allerpops.com.