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Effect of Bifidobacterium lactis oil drops on the management of eczema in infants: a randomized double-blind parallel contrast study

Effect of Bifidobacterium lactis oil drops on the management of eczema in infants: a randomized double-blind parallel contrast study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045308
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-21
Completion date
Unknown
Last updated
2021-11-22

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

Conditions

eczema of infants

Interventions

Intervention group:Daily quantitative administration of bifidobacterium lactis BB12 probiotic oil drops (6 drops each time, once a day)
Control group:Daily ration of oil drops of lactobacillus bifidobacterium BB12 probiotics

Sponsors

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

Eligibility

Sex/Gender
All
Age
0.1 Years to 1 Years

Inclusion criteria

Inclusion criteria: 1.Meeting Williams diagnostic criteria for atopic dermatitis: (3 or more major criteria plus 3 minor criteria); 2.Aged 30 days - 12 months; 3.Full-term infants, 37<= gestational age <42 weeks with birth weight between 2500-4000 g; 4.No antibiotics, probiotics, or other medications or foods were given within 2 weeks; 5.Willing to participate the treatment and make the regular visit; 6.Willing to provide written informed consent.

Exclusion criteria

Exclusion criteria: 1.With metabolic disease, genetic disease or chronic disease; 2.Participating another clinical trial; 3.During the follow-up period, other diseases such as bronchitis and pneumonia need to be treated with antibiotics.

Design outcomes

Primary

MeasureTime frame
SCORAD Index;Gut microbial compositions;

Secondary

MeasureTime frame
Body weight and height;Personal quality of life;Family life impact index;

Countries

China

Contacts

Public ContactJia Jie

Shanghai Jiaotong University School of Medicine

jie.jia@shsmu.edu.cn+86 13122322289

Outcome results

None listed

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