Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age4-12
SponsorWecare Probiotics Co., Ltd.

About this trial

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.

Eligibility criteria

Qualifiers

Voluntarily, in writing, sign the informed consent form, agreeing to participate in this study;

Capable of completing the study according to the test protocol requirements;

Age between 4 to 12 years old;

Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (Revised Edition 2022)";

Disqualifiers

Use of medications affecting the gut microbiota (including antimicrobial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines, etc.) for more than 1 week within 1 month prior to screening;

Patients with coexisting pulmonary tuberculosis;

Those with coexisting allergic asthma;

Individuals with nasal polyps or severe nasal septal deviation;

Trial design

Treatments tested in this trial

  • probiotic product
  • Maltodextrin

Treatment groups

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators