No registrations found.
ID
Source
Brief title
Health condition
Atopic Dermatitis
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
1. The severity of exacerbations of atopic dermatitis, measured by SCORAD, Adverse Events and concomitant medication;
2. The amount and class of topical steroids used;
3. The severity of asthma-like symptoms and asthma medication use.
Background summary
In this study the effect of an added synbiotic mixture in infant formula compared to infant formula without a synbiotic mixture will be assessed in children with atopic dermatitis. After screening subjects will be randomly allocated to receive either the infant formula with synbiotics or the infant formula without synbiotics for a period of 16 weeks. During this intervention period parents will be contacted by phone 3 times every 4 weeks to check how the subject is doing. In case of the occurrence of exacerbations of AD in the subjects during the study the parents will be asked to visit the hospital. After the 16 weeks intervention, the parents will visit the hospital for a final check.
Study objective
A positive effect of using test product with respect to the change of SCORAD after 4 months of intervention in subjects with atopic dermatitis.
Study design
Screening (week -2), Baseline (week 0), Phone call 1 (week 4), Phone call 2 (week 8), Phone call 3 (week 12), End of study visit (week 16).
Intervention
Duration of intervention: 4 months.
Intervention group: Receiving an extensively hydrolyzed whey protein based infant formula with a synbiotic mixture (≥ 500ml/day) for a period of 4 months.
Control group: Receiving an extensively hydrolyzed whey protein based infant formula without a synbiotic mixture (≥ 500ml/day) for a period of 4 months.
Gerda van Wijhe
PO box 80141
Utrecht 3508TC
The Netherlands
+31 30 209 5000
clinicalresearch.nutricia@danone.com
Gerda van Wijhe
PO box 80141
Utrecht 3508TC
The Netherlands
+31 30 209 5000
clinicalresearch.nutricia@danone.com
Inclusion criteria
1. Infants/children with atopic dermatitis;
2. Between 0-8 months of age;
3. Expected daily intake of at least 500ml of the study product;
4. Written informed consent of both parents / legal representative(s).
Exclusion criteria
1. Intolerance for any other component of the study product(s);
2. History of anaphylactic reaction to cow's milk protein, including severe cardiovascular symptoms (shock), severe laryngeal edema, and bronchus obstruction;
3. Use of antihistamines prior to (48 hours) the study;
4. Use of oral steroids prior to (4 weeks) the study;
5. Use of antibiotics or anti-mycotic drugs prior to (4 weeks) the study;
6. History or presence of cardiovascular, gastrointestinal, hepatic, renal or respiratory chronic disease other than allergy;
7. Major congenital abnormalities;
8. Investigator's uncertainty about the willingness or ability of the parents to comply with the protocol requirements.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL3279 |
| NTR-old | NTR3447 |
| Other | Top Institute Pharma : SYN.3.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |