Probiotics Improve Adult Allergic Rhinitis and Regulate Gut Microbiota

NCT06885346 | Completed

• 1 other identifier: WK20250313
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Allergic Rhinitis

Outcome Measures

Primary Outcomes (1)

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

  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.

  8 weeks

Study Arms (2)

Probiotic Group

EXPERIMENTAL

Probiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily.

Dietary Supplement: Probiotic

Placebo Group

PLACEBO COMPARATOR

Gummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day.

Dietary Supplement: Placebo

Interventions

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.

Probiotic Group

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.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.-

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Wecare Probiotics Co., Ltd.: lead

Study Sites (1)

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

Luoyang, Henan, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 20, 2025
• Study Start: November 2, 2024
• Primary Completion: December 28, 2024
• Study Completion: February 25, 2025
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

CN (1)