Study on alleviation of infantile/children eczema by supplementation human milk-derived Lactobacillus reuteri through activating retinol metabolism of ileum dendritic cells

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300072078

Enrollment

Unknown

Registered

2023-06-01

Start date

2023-07-01

Completion date

Unknown

Last updated

2023-06-12

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

Conditions

infantile/children eczema

Interventions

mother FN041 intervention group,:Lactobacillus reuteri FN041 solid drink

children FN041 intervention group:Lactobacillus reuteri FN041 solid drink

mother control group:placebo

children control group:placebo

Eligibility

Sex/Gender

All

Age

1 Years to 40 Years

Inclusion criteria

Inclusion criteria: The inclusion criteria for children weaned as follows: (1) 3 months ~ 12 months of age for lactating infants, and 1~10 years old for weaned infants; (2) obvious atopic dermatitis that meets Williams criteria (symptoms lasting 4 weeks or more) with mild to moderate severity of eczema symptoms at enrollment (SCORAD index score less than 50); (3) be able to provide stool samples; (4) The mother and the child's guardian sign an informed consent form. Nursing mother inclusion criteria: (1) be able to provide stool and breast milk samples; (2) Sign an informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for children: (1) severe eczema (SCORAD score > 50); (2) Receiving antibiotics, systemic corticosteroids, immunosuppressive or Chinese herbal therapy within 4 weeks prior to enrollment; (3) exposure to commercial probiotic products within the past 4 weeks; (4) acute gastrointestinal infection; (5) chronic underlying disease or baseline factors leading to infection (e.g., neurological, metabolic, chronic respiratory disease, congenital heart, gastrointestinal or pulmonary abnormalities); (6) Suffering from known or suspected immunodeficiency; (7) Premature birth. Exclusion criteria for nursing mothers: (1) age below 18 years; (2) maternal immunodeficiency, or taking immunosuppressants; (3) long-term continuous use of probiotics, or deemed unsuitable for inclusion in the study for any other medical reason.

Design outcomes

Primary

Measure	Time frame
scoring atopic dermatitis index;eczema area and severity index;	—

Secondary

Measure	Time frame
infant‘s dermatitis life quality index;child’s dermatitis life quality index;dermatitis family impact questionnaire;Changes in the composition of fecal flora;	—

Countries

China

Contacts

Public ContactCe Qi

Medical College of Qingdao University

ceqi@qdu.edu.cn+86 181 5155 9929

Outcome results

None listed

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