Lacticaseibacillus Rhamnosus LRa05 for Alleviating Allergic Rhinitis in Children

NCT06699537 | Not Yet Recruiting

• 1 other identifier: WK2024016
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Allergic Rhinitis (AR)

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  8 weeks

Study Arms (2)

Probiotic group

EXPERIMENTAL

Participants in the probiotic group received 1 sachet probiotic product per day.

Dietary Supplement: probiotic product

Placebo group

PLACEBO COMPARATOR

Participants in the placebo group received 3g of maltodextrin per day.

Dietary Supplement: Maltodextrin

Interventions

probiotic product DIETARY_SUPPLEMENT

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.

Probiotic group

Maltodextrin DIETARY_SUPPLEMENT

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.

Placebo group

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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;
• No history of heart, liver, kidney, nervous system, mental disorders, or metabolic abnormalities.

You may not qualify if:

• 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.);
• Those with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
• Individuals with sinusitis, otitis media, or respiratory tract infections;
• Those allergic to any components of the probiotics used in this trial;
• Women who are pregnant or breastfeeding, or those planning to conceive in the near future;
• Subjects who discontinue the test sample or add other medications midway, making it impossible to determine efficacy or with incomplete information;
• Those who have recently consumed items similar to the test product, affecting the judgment of the results;
• Subjects who, due to their own reasons, cannot participate in the trial;

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Qilu Hospital of Shangdong University

Jinan, Shangdong, 250012, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Central Study Contacts

Lixiang Li

CONTACT

18560082215; lilixiang@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double(Participant,Investigator)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 21, 2024
• Study Start: December 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 21, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)