Skip to content

Translational applications of products for allergic diseases based on probiotic-assisted therapy

Translational applications of products for allergic diseases based on probiotic-assisted therapy

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600125339
Enrollment
Unknown
Registered
2026-05-25
Start date
2026-05-26
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

Allergic rhinitis

Interventions

Group A:The probiotic combination of animal bifidobacterium lactis subspecies Bb-12 + rhamnolipid cheese GG + rhamnolipid cheese HN001 + short bifidobacterium M-16V in combination with drug treatment
Group B:The conventional drug treatment group

Sponsors

Shanghai Children's Medical Center, Affiliated to Shanghai Jiao Tong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 8 Years

Inclusion criteria

Inclusion criteria: Children with allergic rhinitis (AR) aged 3–8 years were enrolled, with AR diagnosed in accordance with the diagnostic criteria specified in the 2019 Revision of the Allergic Rhinitis and its Impact on Asthma (ARIA) Guidelines. The diagnostic criteria are as follows: 1. Symptoms: Presence of two or more of the following symptoms (watery rhinorrhea, nasal itching, nasal obstruction, and sneezing), with daily symptom duration of at least 1 hour (either continuously or cumulatively). Ocular symptoms such as ocular itching and conjunctival hyperemia may be accompanied. Severe cases may exhibit the allergic salute maneuver. 2. Signs: Common findings include pale and edematous nasal mucosa with watery nasal discharge. Severe cases may present with allergic shiners or allergic creases. 3. Laboratory evidence: In addition to the aforementioned clinical manifestations (symptoms and signs), serum-specific immunoglobulin E (sIgE) testing should confirm positivity for specific inhalant allergens (> 0.35 kU/mL).

Exclusion criteria

Exclusion criteria: 1. Comorbid with allergic asthma and atopic dermatitis; 2. Comorbid with chronic active urticaria; 3. Receiving immunosuppressive therapy; 4. Having undergone allergen-specific immunotherapy (AIT) within the past year; 5. Having used probiotics, prebiotics or antibiotics within the past 3 months; 6. Having received corticosteroid therapy for more than 1 week within the past 3 months; 7. Comorbid with autism, depression or obesity (BMI > 30); 8. Comorbid with severe primary diseases involving the heart, liver, kidneys, hematopoietic system or other vital organs; 9. The patient or their immediate family members suffering from immunodeficiency or autoimmune diseases (e.g., inflammatory bowel disease, ulcerative colitis, irritable bowel syndrome, etc.); 10. Having constipation or diarrhea lasting for >=6 months.Additionally, children with severe immunodeficiency or acute exacerbation of chronic diseases were excluded.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale (VAS);Rhinitis Control Assessment Test (RCAT);

Secondary

MeasureTime frame
Allergen Skin Prick Test (SPT) ;Serum-specific Immunoglobulin E (sIgE) Test;

Countries

China

Contacts

Public ContactYoujin Li

Shanghai Children's Medical Center, Affiliated to Shanghai Jiao Tong University School of Medicine

kevinliyoujin@163.com+86 21 3420 6890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jun 11, 2026