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A prospective randomized controlled clinical trial of probiotics in the treatment of patients with allergic rhinitis

A prospective randomized controlled clinical trial of probiotics in the treatment of patients with allergic rhinitis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400090953
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-07-17
Completion date
Unknown
Last updated
2024-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic rhinitis

Interventions

Probiotic group:Probiotics were started before the pollen dispersal period for a total of 12 weeks. If symptoms occur during pollen dispersal, use conventional medications (cetirizine tablets and bude
Placebo group:Placebo was started before the pollen dispersal phase for a total of 12 weeks and continued throughout the pollen dispersal phase. If the patient develops symptoms during pollen dispersa

Sponsors

Hohhot First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 69 Years

Inclusion criteria

Inclusion criteria: 1. In this study, all patients with AR had a history of seasonal (autumn) allergies, but were enrolled before pollen spread, that is, before the onset of symptoms. 2. Both male and female, aged from 18 to 69 years; 3. A history of a typical seasonal allergic rhinitis, the diagnosis of seasonal AR with Chinese guide to diagnosis and treatment of allergic rhinitis (2022 edition); 4. Symptoms: there were 2 or more symptoms such as paroxysmal sneezing, clear watery discharge, nasal itching and nasal congestion. The symptoms lasted or accumulated for more than 1 hour every day, and could be accompanied by eye symptoms such as tears, itching and redness. 5. Physical signs included pale and edema of nasal mucosa and watery nasal discharge. 6. Allergen testing in the past or at the visit: at least one allergen SPT and/or serum specific IgE positive; 7. The patients had symptoms for more than 4 weeks in the previous pollen seeding season; 8. Voluntary subjects and signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients with perennial allergic rhinitis, severe deviation of nasal septum, sinusitis and nasal polyps; 2. Patients with severe heart, liver, kidney, brain disease; 3. Pregnancy and lactation women; 4. Patients were treated with tricyclic antidepressants, immunosuppressive / immunomodulatory agents, and oral corticosteroids 4 weeks before enrollment. 5. Prolonged antibiotic treatment within 1 month before enrollment; 6. A history of Clostridium difficile infection within the past three months; 7. Patients who have undergone major surgery in the past three months; 8. Those who are allergic to probiotics or other ingredients; 9. Other circumstances that are considered unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
Symptom scores based on a quadrangular scale and therapeutic effectiveness;

Secondary

MeasureTime frame
Symptom score based on Visual Analogue Scale (VAS);Total medication scores, TMS;Time to end and duration of symptoms;Routine blood tests;Peripheral blood cytokine;Gut microbiota;Nasal microbes;Feca and serum metapolites;

Countries

China

Contacts

Public ContactJunjing Zhang

Hohhot First Hospital

zhang.jj@vip.163.com+86 135 0069 6309

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026