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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic Group | Experimental | Probiotic soft candies containing Weizmannia coagulans BC99, 10 billion CFU per piece, to be chewed directly, 2 pieces daily. |
|
| Placebo Group | Placebo Comparator | Gummies without Weizmannia coagulans BC99, to be chewed directly, 2 pieces per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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. -
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Food and Bioengineering, Henan University of Science and Technology | Luoyang | Henan | China |
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| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| ID | Term |
|---|---|
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| 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. |
|
| D010038 |
| Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D019602 |
| Food and Beverages |