Probiotic Ameliorates Adult Allergic Rhinitis and Modulates Gut Microbiota

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Maltodextrin

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Henan
    • Luoyang, Henan, China, 471000
      • School of Food and Bioengineering, Henan University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Voluntarily and in writing, sign an informed consent form agreeing to participate in this study;
2. Able to complete the study as required by the trial protocol;
3. Age between 18 and 65 years old;
4. Meet the diagnostic criteria for allergic rhinitis established in the "Chinese Guidelines for the Diagnosis and Treatment of Allergic Rhinitis (2022 Revised Edition)";
5. 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;
6. Signs: Pale and edematous nasal mucosa, which may be accompanied by watery secretions.

Exclusion Criteria:

1. 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;
2. Patients with coexisting pulmonary tuberculosis;
3. Patients with coexisting allergic asthma;
4. Patients with nasal polyps or severe nasal septum deviation;
5. Patients with severe systemic diseases or malignant tumors;
6. Individuals with congenital genetic diseases or congenital immunodeficiency diseases;
7. Regular use of probiotics or prebiotics within 6 months prior to the screening period;
8. Patients with severe gastrointestinal diseases (including severe diarrhea, inflammatory bowel diseases, etc.);
9. Individuals with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
10. Patients with sinusitis, otitis media, or respiratory tract infections;
11. Individuals allergic to any components of the probiotics used in this trial;
12. Pregnant or lactating women or those planning to conceive in the near future;
13. Those who discontinue the test sample or take other medications midway, making it impossible to determine efficacy or with incomplete data;
14. Recent use of products similar to the test function, affecting the judgment of the results;
15. Participants who cannot participate in the trial due to their own reasons;
16. Other participants deemed ineligible by the researcher.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic Group; Probiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.	Dietary supplement: Probiotic; The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.
Placebo Comparator: Placebo Group; Gummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day. Storage method: Keep away from light, seal tightly, and store in a cool, dry place.	Dietary supplement: Maltodextrin; The experimental phase of this study lasts for 8 weeks, with each patient making three visits at weeks 1, 4, and 8.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement of rhinitis symptoms in participants	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.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
16S rRNA sequencing was used to evaluate the changes of intestinal flora before and after the intervention	Changes in subjects' fecal microbiota, including abundance and proportion of beneficial bacteria, were assessed by 16S rRNA sequencing before and after probiotic intervention.	8 weeks
Effect of probiotic intervention on immunoglobulin in subjects	The changes of Immunoglobulin A and Immunoglobulin E before and after intervention were detected by ELISA.	8 weeks
Impact on Serum Inflammatory Cytokines	Levels of IL-4, IL-5, IL-10, IL-13.	8 weeks

Collaborators and Investigators

• Sponsor: Wecare Probiotics Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2024
• Primary Completion (Actual): December 25, 2024
• Study Completion (Actual): March 25, 2025

Study Registration Dates

• First Submitted: November 4, 2024
• First Submitted That Met QC Criteria: November 6, 2024
• First Posted (Actual): November 8, 2024

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 1, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: WK2024010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No