Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

NCT06676111 | Completed

• 1 other identifier: WK2024009
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.

Conditions

Children With Allergic Rhinitis

Outcome Measures

Primary Outcomes (4)

• Total Nasal Symptom Score (TNSS)

  Score 0 - asymptomatic; Score 1 - mild symptoms, easily tolerated; Score 2 - moderate symptoms, annoying but tolerable; Score 3 - Severe symptoms, intolerable, affecting daily life and sleep. Add them together to get the total score

  56 days

• Visual Analogue Scale (VAS)

  "0" means no such symptoms; "10" means that this symptom is the most severe. Add them together to get the total score

  56 days

• Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)

  0 points: no trouble; 1 point: little to no distress; 2 points: occasional distress; Score 3: Moderate degree of distress; 4: Somewhat bothered, 5: Very bothered; Score 6: Extremely distressed

  56 days

• Medication scores

  Scoring drugs include oral antihistamines (3 points/tablet, maximum 6 points), oral leukotriene receptor antagonists (2 points/dose), nasal glucocorticoids (1 point/spray, maximum 8 points), nasal spray or eye drops antihistamines (0.5 points/spray or drop, maximum 4 points), and the daily average score for the past 1 week was calculated.

  56 days

Study Arms (2)

Probiotic group

EXPERIMENTAL

Probiotic pectin gummies(2 billion CFU)/2 pellets/day BC99; Storage: Store in a cool, dry place without sun exposure.

Dietary Supplement: Probiotic

Placebo group

PLACEBO COMPARATOR

No probiotic pectin gummies/2 pellets/day; Storage: Store in a cool, dry place without sun exposure.

Dietary Supplement: Placebo

Interventions

Probiotic DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)

Probiotic group

Placebo DIETARY_SUPPLEMENT

The experimental phase of this study lasts 56 days and each patient will have 3 visits (W0, W4, W8)

Placebo group

Eligibility Criteria

• Age: 4 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Voluntary, written, and signed informed consent form, agreeing to participate in this study;
• Capable of completing research according to the requirements of the experimental plan;
• Age range: 4-14 years old;
• Meets the diagnostic criteria for AR established in the "Guidelines for Diagnosis and Treatment of Allergic Rhinitis in Children (Revised 2022)";
• Symptoms: Two or more symptoms appear: sneezing, watery nasal discharge, nasal itching, and nasal congestion. Symptoms last or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, tearing, and redness;
• Physical signs: pale and edematous nasal mucosa, accompanied by watery discharge.

You may not qualify if:

• Drugs that affect the intestinal flora (including antibacterial drugs, probiotics, intestinal mucosal protective agents, traditional Chinese patent medicines and simple preparations, etc.) are continuously used for more than one week within one month before screening;
• Merge with tuberculosis patients;
• Combined with allergic asthma;
• Patients with nasal polyps or severe nasal septum deviation;
• Patients with serious systemic diseases or malignant tumors;
• Individuals with congenital genetic disorders or congenital immunodeficiency diseases;
• Regular use of probiotics or prebiotics within the first 6 months of the screening period;
• Individuals with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel disease, etc.);
• Those with metabolic syndrome (including obesity, abnormal lipid metabolism, hypertension, diabetes, etc.);
• Patients with combined sinusitis, otitis media, or respiratory infections;
• Stop taking the test sample or add other drugs midway, unable to determine efficacy or incomplete data;
• Short term use of substances with similar functions to the test subject affects the judgment of the results;
• The subject is unable to participate in the trial due to personal reasons;
• Participants deemed unsuitable by other researchers to participate. Those who meet any of the above conditions shall not be selected.

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Location

Related Publications (1)

• Han Z, Zhu H, Yang Y, Wang Y, Li X, Zhu J, Wu Y, Fang S, Gu S. Weizmannia coagulans BC99 alleviates pediatric allergic rhinitis via the gut microbiota-SCFAs- immunomodulatory axis: A randomized, double-blind, placebo-controlled trial. Int Immunopharmacol. 2026 Jan 1;168(Pt 1):115787. doi: 10.1016/j.intimp.2025.115787. Epub 2025 Nov 5.

  PMID: 41197269 DERIVED

MeSH Terms

Interventions

Probiotics

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

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

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 6, 2024
• Study Start: October 10, 2024
• Primary Completion: February 10, 2025
• Study Completion: July 31, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

CN (1)