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Completed

NCT Number: NCT06676111

Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children

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.

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Key information

Age range

4 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Henan University of Science and Technology

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Probiotic

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  1. Total Nasal Symptom Score (TNSS)

    Time frame: 56 days

    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

  2. Visual Analogue Scale (VAS)

    Time frame: 56 days

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

  3. Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)

    Time frame: 56 days

    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

  4. Medication scores

    Time frame: 56 days

    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.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 6, 2024
Registry last updated
Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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