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Completed

NCT Number: NCT06885346

Probiotics Improve Adult Allergic Rhinitis and Regulate 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, 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.

Placebo

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. The variations in intestinal flora before and after the intervention were assessed using 16S rRNA sequencing.

    Time frame: 8 weeks

    16S rRNA sequencing was performed to assess changes in the fecal microbiota of the subjects before and after the probiotic intervention, including the abundance and proportion of beneficial bacteria.

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
Mar 20, 2025
Registry last updated
Mar 20, 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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