The clinical trial aims to investigate the efficacy of Lactobacillus rhamnosus LRa05 in alleviating allergic rhinitis and its impact on the gut microbiota among 70 pediatric participants aged 4-12. The primary objective is to validate the improvement in allergic rhinitis symptoms following an 8-week intervention with Lactobacillus rhamnosus LRa05. Participants were instructed to consume the probiotic powder daily for approximately 8 weeks. At baseline, week 4, and week 8 endpoints, assessments of nasal symptoms, quality of life questionnaires, and stool samples for microbiota analysis were conducted on the participants, and blood samples were collected for immune-related factor testing.
Research has indicated that allergic rhinitis (AR) is associated with a decrease in the diversity of the gut microbiota, particularly in children, potentially linking to the development of allergic diseases. Preclinical studies have shown that supplementation with Lactobacillus rhamnosus LRa05 can regulate immune responses, inhibit inflammatory factors, and the predictive functions of the gut microbiota suggest an increase in gene abundance within pathways related to immune modulation, anti-inflammatory effects, and maintenance of gut barrier integrity. To ascertain the effectiveness of the probiotic strain LRa05, a randomized, double-blind, placebo-controlled trial was conducted by the investigators to evaluate and gather data on alterations in the gut microbiota and allergic rhinitis symptoms among pediatric participants. The trial spanned over 8 weeks, with washout periods incorporated at the commencement and conclusion. Throughout the study, participants ingested Lactobacillus rhamnosus LRa05 and were subjected to a series of health examinations and assessments, including nasal symptom scores, quality of life questionnaires, and stool sample collections for microbiota analysis, as well as blood samples for immune-related factor testing. The primary objective was to validate the improvement in allergic rhinitis symptoms and the modulation of the gut microbiota following the intervention with LRa05.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
70
During the study, subjects take one sachet of Lactobacillus rhamnosus LRa05 daily. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the intervention.
During the study, subjects in the control group take one sachet of maltodextrin daily with 3.0g. Evaluation is conducted by monitoring the subjects' nasal symptoms and gut microbiota before and after the 8-week trial.
Qilu Hospital of Shangdong University
Jinan, Shangdong, China
Change in Total Nasal Symptom Score (TNSS)
The Total Nasal Symptom Score (TNSS) will be used to assess the severity of nasal symptoms in subjects. TNSS includes four symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion, each rated by the patient on a severity scale (0 points indicate no symptoms; 1 point indicates mild symptoms, easily tolerable; 2 points indicate moderate symptoms, annoying but tolerable; 3 points indicate severe symptoms, intolerable, affecting daily life and sleep). The total score is the sum of the individual symptom scores, ranging from 0 to 12, with higher scores indicating more severe symptoms. The TNSS scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
Time frame: 8 weeks
Change in Visual Analogue Scale (VAS) for Nasal Symptoms
The Visual Analogue Scale (VAS) will be used to evaluate the treatment effect in subjects. VAS scores pertain to four nasal symptoms: sneezing, rhinorrhea, nasal itching, and nasal congestion, with patients marking a point on a 0-10 cm line (0 indicates no symptoms, 10 indicates the most severe symptoms). The total score is the sum of the individual symptom scores, ranging from 0 to 40, with higher scores indicating more severe symptoms. The VAS scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
Time frame: 8 weeks
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) will be used to assess the quality of life in subjects. The RQLQ consists of 28 questions that evaluate the degree to which subjects have been bothered by problems in the past 7 days (0 points indicate not bothered at all; 1 point indicates hardly bothered; 2 points indicate occasionally bothered; 3 points indicate moderately bothered; 4 points indicate quite a bit bothered; 5 points indicate very bothered; 6 points indicate extremely bothered). The total score is the sum of the individual question scores, ranging from 0 to 168, with higher scores indicating a greater impact on quality of life. The RQLQ scores at baseline and after the 8-week intervention will be recorded and the change will be calculated.
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.