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NCT Number: NCT07532837

The Effect of Oral Probiotics on Allergic Rhinitis Symptoms and the Quality of Life

Allergic rhinitis (AR), also known as nasal allergy, hay fever or seasonal allergic rhinitis, is an inflammatory condition of the nasal passages caused by the immune system's response to allergens in the air. Symptoms include runny or blocked nose, nasal itching, sneezing, and red, itchy, and watery eyes. These symptoms typically occur within minutes of exposure to allergens and can affect sleep, work productivity, and concentration during learning. Many patients with allergic rhinitis also suffer from conditions such as asthma, allergic conjunctivitis, or atopic dermatitis.Symptoms in the majority of patients tend to recur and persist over time. While medication can alleviate the symptoms, complete cure is challenging to achieve.

Probiotics are generally defined as microorganisms that, when ingested, provide beneficial effects to the host. They primarily consist of bacteria that produce lactic acid, including Lactobacilli, Bifidobacteria, and Saccharomyces boulardii. One known mechanism underlying allergic diseases is the overactivation of Th2 cells, leading to an imbalance in the Th1/Th2 ratio. Previous research has explored whether the use of probiotics can prevent allergic diseases. Numbers of studies indicate that probiotics have the ability to modulate the immune system by increasing anti-inflammatory cytokines such as IFN-γ, IL-10, and IL-12 to enhance Th1 cell activity. Simultaneously, they suppress pro-inflammatory cytokines like IL-4, IL-5, and IL-13, inhibiting excessive Th2 activation and restoring Th1/Th2 balance to improve symptoms.

Current evidence from clinical randomized controlled trials suggests that supplementation with probiotics during pregnancy and early infancy can prevent allergies or the development of more severe allergic conditions. However, regarding AR, current research has confirmed that probiotic consumption can improve the quality of life and the severity of nasal symptoms (measured by PRQLQ and TNSS) in AR patients. Nevertheless, the efficacy of regulating AR varies based on different strains or species of probiotics used.

This project aims to select probiotic strains that enhance the function of regulatory T cells (Treg cells), thereby promoting the secretion of Th1 cell cytokines IL-12 and IFN-γ to assist in achieving Th1/Th2 immune balance. This approach aims to reduce specific immunoglobulin E (IgE) levels and achieve an anti-inflammatory effect, thereby improving the regulation of allergic reactions within patients' bodies.

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This study is active but is not currently recruiting participants.

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Key information

Age range

6 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

China Medical University Hospital

Taichung, 404, Taiwan

Who can participate

Healthy volunteers accepted: No

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

  • Inclusion criteria:
  • Age between 6 and 65 years.
  • Diagnosed with allergic rhinitis by a qualified physician.
  • Score ≥ 7 on the Score for Allergic Rhinitis (SFAR).
  • Willing to participate and has signed the informed consent form.
  • Exclusion criteria:
  • History of drug allergy or use of medications with high sensitivity or contraindications (e.g., allergy to antibiotics or antipyretics).
  • Patients with rhinitis symptoms caused by structural abnormalities such as a deviated nasal septum.
  • Patients receiving oral corticosteroid therapy.
  • Consumption of probiotic-related products within the past 1 month (including drops, tablets, capsules, powders, yogurt, or fermented milk containing live bacteria).
  • Participation in other clinical studies within the past 1 month.
  • Receipt of immunotherapy within the past 1 year.
  • Presence of major illnesses (e.g., possession of a catastrophic illness certificate) or severe immune, hematological, or congenital disorders.
  • Deemed unsuitable for participation by a physician.

Treatment and study plan

Lactobacillus rhamnosus F-1

Dietary Supplement

Take one packet of probiotics (Lactobacillus rhamnosus F-1) twice daily.

Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104

Dietary Supplement

Take one packet of probiotics (Lactobacillus rhamnosus F-1、Lactobacillus reuteri GL-104) twice daily.

Placebo

Dietary Supplement

Subjects take two capsules daily.

Primary outcomes

  1. Changes in Score for Allergic Rhinitis(SFAR)

    Time frame: Baseline (pre-intervention).

    The score ranges from 0 to 16 and includes 8 items. A higher score indicates a more severe severity.

  2. Changes in blood biochemical inflammatory markers.

    Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation。

    Changes in the levels of IgE, ECP, CBC, IL-4, IL-10, IL-12, IFN-γ, TGF-β, Vitamin D3, IL-17, and TNF-α.

  3. Analysis of gut microbiota composition

    Time frame: Baseline (pre-intervention) and after 12 weeks of probiotic supplementation.

    Changes in gut microbiota ratios were assessed using NGS before and after the intervention.

  4. Changes in the Score for Allergic Rhinitis and Rhinoconjunctivitis Quality of Life Questionnaire(RQLQ)

    Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.

    It includes 28 items across 7 areas (activity, sleep, non-nasal/eye symptoms, practical problems, nasal symptoms, eye symptoms, and emotions). Using a 7-point scale (0 = no trouble, 6 = extreme trouble), the lower the score, the better the quality of life.

Secondary outcomes

  1. Changes in Visual Analogue Scale(VAS) scores

    Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.

    The higher the number from 1 to 10, the more uncomfortable it feels.

  2. Changes in Total nasal symptoms score (TNSS).

    Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.

    It typically sums scores for four symptoms-nasal congestion, rhinorrhea (runny nose), nasal itching, and sneezing-each rated 0-3, resulting in a maximum total score of 12.A lower score indicates better control or improvement of nasal symptoms.

  3. Changes in Rhinitis Control Assessment Test (RCAT) scores

    Time frame: Baseline (pre-intervention), after 12 weeks of probiotic supplementation, and 8 weeks after discontinuation.

    The questionnaire contains 6 items, with a total score range of 6-30 points. The lower the score, the worse the rhinitis control is usually.

Sponsors and collaborators

Lead sponsor

Glac Biotech Co., Ltd

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2026
Registry last updated
Apr 16, 2026

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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