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Completed

NCT Number: NCT06680102

Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

Assessing the clinical efficacy of weizmannia coagulans BC99 in alleviating allergic rhinitis symptoms, improving gut microbiota, and reducing adverse reactions in patients.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Food and Bioengineering, Henan University of Science and Technology

Luoyang, Henan, 471000, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Voluntarily and in writing, sign an informed consent form agreeing to participate in this study;
  • Able to complete the study as required by the trial protocol;
  • Age between 18 and 65 years old;
  • Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)";
  • Symptoms: Presence of two or more symptoms such as sneezing, watery rhinorrhea, nasal itching, and nasal congestion, with daily symptoms lasting or accumulating for more than 1 hour, which may be accompanied by eye itching, tearing, and redness of the eyes and other ocular symptoms;
  • Signs: Pale and edematous nasal mucosa, which may be accompanied by watery secretions.

Exclusion criteria

  • Use of drugs affecting the gut microbiota (including antimicrobial agents, 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;
  • Patients with coexisting allergic asthma;
  • Patients with nasal polyps or severe nasal septum deviation;
  • Patients with severe systemic diseases or malignant tumors;
  • Individuals with congenital genetic diseases or congenital immunodeficiency diseases;
  • Regular use of probiotics or prebiotics within 6 months prior to the screening period;
  • Patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);
  • Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
  • Patients with sinusitis, otitis media, or respiratory tract infections;
  • Individuals allergic to any components of the probiotics used in this trial;
  • Pregnant or lactating women or those planning to conceive in the near future;
  • Those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data;
  • Recent use of products similar to the test function, affecting the judgment of the results;
  • Participants who cannot participate in the trial due to their own reasons;
  • Other participants deemed ineligible by the researcher.

Treatment and study plan

Probiotic

Dietary Supplement

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Maltodextrin

Dietary Supplement

The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

Primary outcomes

  1. Improvement of rhinitis symptoms in participants

    Time frame: 8 weeks

    Improvement in Nasal symptoms was assessed using the Total Nasal Symptom Score(TNSS), which included four common nasal symptoms: itchiness, nasal congestion, sneezing, and runny nose. The four symptoms were scored using a "four-point scale", that is, according to the severity of each symptom from 0 to 3 points, that is, the higher the score, the more severe the symptoms, and the total score of the entire TNSS score is the sum of the four symptom scores, which ranges from 0 to 12 points.

Secondary outcomes

  1. 16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention

    Time frame: 8 weeks

    Changes in subjects' fecal microbiota, including abundance and proportion of beneficial bacteria, were assessed by 16S rRNA sequencing before and after probiotic intervention.

  2. Effect of probiotic intervention on immunoglobulin in subjects

    Time frame: 8 weeks

    The changes of Immunoglobulin A and Immunoglobulin E before and after intervention were detected by ELISA.

  3. Impact on Serum Inflammatory Cytokines

    Time frame: 8 weeks

    Levels of IL-4, IL-5, IL-10, IL-13.

Sponsors and collaborators

Lead sponsor

Wecare Probiotics Co., Ltd.

Industry

Registry information

Official study title

The Effectiveness of Weizmannia Coagulans BC99 in Alleviating Allergic Rhinitis in Adults and Its Impact on the Gut Microbiota.

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Nov 8, 2024
Registry last updated
Jul 4, 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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