Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children (NCT06699537) | Clinical Trial Compass
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 range
4 Years – 12 Years
Sex
ALL
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;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Total Nasal Symptom Score (TNSS)
Timeframe: 8 weeks
2
Change in Visual Analogue Scale (VAS) for Nasal Symptoms
Timeframe: 8 weeks
3
Change in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)
. 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
. 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;
. Patients with severe systemic diseases or malignant tumors;
. Those with congenital genetic diseases or congenital immunodeficiency diseases;
. Regular use of probiotics or prebiotics within 6 months prior to the screening period;
. Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);