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Efficacy and safety of Bifidobacterium longum CCFM1029 and Lactobacillus casei CCFM1073 in the treatment of infant atopic dermatitis

Efficacy and safety of Bifidobacterium longum CCFM1029 and Lactobacillus casei CCFM1073 in the treatment of infant atopic dermatitis

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078619
Enrollment
Unknown
Registered
2023-12-14
Start date
2024-01-01
Completion date
Unknown
Last updated
2023-12-19

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

Conditions

atopic dermatitis

Interventions

Placebo group:Oral supplementation of probiotic ingredients for 12 weeks
Bifidobacterium longum group:Oral supplementation of Bifidobacterium longum CCFM1029 for 12 weeks
Lactobacillus casei group:Oral supplementation of Lactobacillus casei CCFM1073 for 12 weeks

Sponsors

Women’s Hospital of Jiangnan University(Wuxi Maternity and Child Health Care Hospital)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 3 Years

Inclusion criteria

Inclusion criteria: Individuals must meet all of the following criteria: (1) infants and young children < 36 months of age; (2) Diagnosed with AD according to Williams criteria; (3) The dermatologist evaluated atopic dermatitis with a SCORAD score =50 (mild to moderate); (4) Parents or guardians sign informed consent.

Exclusion criteria

Exclusion criteria: Individuals who meet any of the following criteria will be excluded from this trial: (1) children with immunodeficiency diseases and immunocompromised children; (2) The child has used systemic immunosuppressants or glucocorticoids or antibiotics in the past 1 month; (3) the child has taken probiotic-related products in the past 2 weeks, or is currently taking probiotics, and does not want to stop; (4) Parents or guardians refuse to sign the informed consent; (5) Children who have participated in a drug study within the past 3 months.

Design outcomes

Primary

MeasureTime frame
SCORing of Atopic Dermatitis;Eczema area and severity index;

Secondary

MeasureTime frame
Investigator Global Assessment;body surface area;Infants’ Dermatitis Quality of Life Index;Dermatitis Family Index;worst scratch and itch Numerical Rating;Sleep quality Numerical Rating;eosinophil count;Total IgE;IL-4;TARC;lymphocyte subsets;drug therapy;Incidence of allergic disease;

Countries

China

Contacts

Public ContactRenqiang Yu

Women’s Hospital of Jiangnan University(Wuxi Maternity and Child Health Care Hospital)

yurenqiang553@163.com+86 150 5067 6990

Outcome results

None listed

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