2.1 Primary study objectiveThe primary objective of this study is to investigate the therapeutic effect of an extensively hydrolyzed protein based infant formula with a synbiotic mixture on the severity of atopic dermatitis in infants.2.2 Secondary…
ID
Source
Brief title
Condition
- Respiratory disorders NEC
- Skin and subcutaneous tissue disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome parameter in this study is the change of SCORAD after 4
months of intervention.
Secondary outcome
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.
Background summary
The addition of a synbiotic mixture to a hydrolyzed infant formula could
influence symptoms of Atopic Dermatitis positively.
A mixture of prebiotics and probiotics seems to improve the immune system and
therefore the skin complaints in infants with Atopic Dermatitis can decrease,
it is also possible that less asthma or asthma-like symptoms will occur.
Study objective
2.1 Primary study objective
The primary objective of this study is to investigate the therapeutic effect of
an extensively hydrolyzed protein based infant formula with a synbiotic mixture
on the severity of atopic dermatitis in infants.
2.2 Secondary study objective(s)
The secondary objective of this study is to investigate the effect of an
extensively hydrolyzed protein based infant formula with a synbiotic mixture in
infants with atopic dermatitis with regard to asthma-like symptoms and asthma
medication use.
Study design
This is a randomized, double-blind, placebo-controlled intervention study.
Intervention
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
mixture.
Study burden and risks
Based on the information we have, we don't expect any risks in participation in
this clinical trial.
Bosrandweg 20
Wageningen 6700 CA
NL
Bosrandweg 20
Wageningen 6700 CA
NL
Listed location countries
Age
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
- 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL39329.018.12 |