A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis.

A randomized, double-blind, placebo-controlled intervention study to assess the therapeutic effect of an extensively hydrolyzed infant formula with an added synbiotic mixture in infants with atopic dermatitis. - SAINT

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39465

Enrollment

144

Registered

2012-03-29

Start date

2012-08-13

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

atopic dermatitis eczema

Interventions

Test product: Extensively hydrolyzed whey protein based infant formula with a synbiotic mixture. Reference product: Extensively hydrolyzed whey protein based infant formula without a synbiotic mix

Eligibility

Age

2 Years to 11 Years

Inclusion criteria

Inclusion criteria: - Infants/children with atopic dermatitis - up to and includig 10 months of age - Expected daily intake of at least 500ml of the study product

Exclusion criteria

Exclusion criteria: - Intolerance for any other component of the study product(s) - History of anaphylactic reaction to cow*s milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction. - Use of antihistamines prior to (48 hours) the study. - Use of oral steroids prior to (4 weeks) the study. - Use of antibiotics or antimycotic drugs prior to (4 weeks) the study. - History or presence of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy. - Major congenital abnormalities. - Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.

Design outcomes

Primary

Measure	Time frame
The primary outcome parameter in this study is the change of SCORAD after 4 months of intervention.	—

Secondary

Measure	Time frame
Secondary outcome parameters in this study are: - The severity of exacerbations of atopic dermatitis. - The amount of topical steroids used. - The severity of asthma-like symptoms and asthma medication use.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)