Not Yet RecruitingNot Applicable

Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children

China70 participantsStarted 2024-12-01

Plain-language summary

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.

Who can participate

Age range4 Years – 12 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)";
✓. Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than one hour per day, possibly accompanied by eye itching, tearing, and redness, and other ocular symptoms;
✓. Signs: Nasal mucosa is pale and edematous, possibly with watery secretions;
✓. Laboratory tests: At least one allergen detected by skin prick test and/or specific IgE positivity in serum;
✓. No use of antihistamines, corticosteroids, or immunosuppressants in the month before screening;

Exclusion criteria

What they're measuring

Change in Total Nasal Symptom Score (TNSS)

Timeframe: 8 weeks

Change in Visual Analogue Scale (VAS) for Nasal Symptoms

Timeframe: 8 weeks

Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)

Timeframe: 8 weeks

Trial details

NCT IDNCT06699537

SponsorWecare Probiotics Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-11-01

Contact for this trial

Lixiang Li

18560082215 lilixiang@sdu.edu.cn

View on ClinicalTrials.gov More Allergic Rhinitis (AR) trials

Plain-language summary

Who can participate

Age range4 Years – 12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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)";
✓. Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with symptoms lasting or accumulating for more than one hour per day, possibly accompanied by eye itching, tearing, and redness, and other ocular symptoms;
✓. Signs: Nasal mucosa is pale and edematous, possibly with watery secretions;
✓. Laboratory tests: At least one allergen detected by skin prick test and/or specific IgE positivity in serum;
✓. No use of antihistamines, corticosteroids, or immunosuppressants in the month before screening;