Effects of synbiotics in infants with atopic dermatitis.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON26088

Enrollment

Registered

2005-08-23

Start date

2005-09-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Atopic Eczema Dermatitis Syndrome

Interventions

Scorad, questionnaires on AEDS symptoms, Blood collection for safety, immunological and immunological parameters. Stool collection for faecal microbiota evaluation.

Eligibility

Inclusion criteria

Inclusion criteria: Main criteria: Term infants, between 0 and 7 months of age, fulfilling standard criteria for AEDS.

Exclusion criteria

Exclusion criteria: Main criteria: Scorad score < 15, use of anti-histamines or systemic corticosteroids or anti-mycotic drugs, Skin disorder other than AEDS.

Design outcomes

Primary

Measure	Time frame
Decrease in Scorad score after 12 weeks of treatment is >25% greater in the active group compared to the placebo group.	—

Secondary

Measure	Time frame
Immunological parameters. Faecal microbiota parameters, Quality of Life of the parents and parental stress, gastro-intestinal tract characteristics.	—

Contacts

Public ContactD.A.M. Goossens

Dominique.Goossens@numico-research.nl+31 317 467 800 (direct line: +31 317 467 805).

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)