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A double-blind controlled study comparing the desensitization effect of selecting a specific strain product using an in vitro pre-test and selecting a probiotic product without using an in-vitro pre-test

A double-blind controlled study comparing the desensitization effect of selecting a specific strain product using an in vitro pre-test and selecting a probiotic product without using an in-vitro pre-test

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200062376
Enrollment
Unknown
Registered
2022-08-03
Start date
2022-08-01
Completion date
Unknown
Last updated
2023-04-12

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

Conditions

allergic rhinitis

Interventions

personalized probiotic adjuvant therapy group:Personalized probiotic products
group of probiotic products without individual screening:Unpaired probiotic products
placebo group:placebo

Sponsors

Wuxi Children's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. 3-12 years old. 2. Clinically diagnosed as IgE-mediated type I allergy patients. 3. The patient must have been diagnosed with rhinitis for at least 6 months, and the patient's immunoglobulin E value is greater than 120 IU/mL, and the eosinophilic white blood cell value is greater than 0.6 × 103/uL. 4. Can cooperate with the collection of experimental specimens and regular return visits. 5. The patient or family members have signed the subject's consent form. 6. All rhinitis and allergy-related drugs can be stopped one month before the trial (the nasal wash can be reserved).

Exclusion criteria

Exclusion criteria: 1. Congenital intestinal abnormalities, such as Hirschsprungs disease or intestinal atresia, were assessed by physicians as not suitable for inclusion in this clinical trial. 2. Other gastrointestinal diseases with symptoms of intestinal inflammation and increased permeability. 3. Those who have taken immunosuppressive drugs, steroids, various antibiotics, and T cell inhibitor ointments within 4 weeks. 4. Non-rhinitis. 5. Clinically diagnosed patients with asthma. 6. The patient has been consuming probiotic-related products (bacteria powder,yogurt or other fermented foods) continuously (for five or more days in a row) in the past month. 7. Those who have participated in other clinical trials and are taking experimental drugs in the past 1 month, use nasal sprays for five or more days a week, use systemic steroids, testosterone, or high-dose anti-inflammatory drugs (such as greater than 600 mg/day of aspirin). 8. During the test period of more than 10 days, no probiotics were taken. 9. Patients who have plans to change their rhinitis medication in the short term. 10. Others who have been evaluated by a physician as unsuitable for entry into the trial.

Design outcomes

Primary

MeasureTime frame
height;weight;fecal microbiota;blood routine;

Countries

China

Contacts

Public ContactWenwei Lu
luwenwei@jiangnan.edu.cn+86 18762691080

Outcome results

None listed

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