A positive effect of using test product with respect to the change of SCORAD after 4 months of intervention in subjects with atopic dermatitis.
ID
Bron
Verkorte titel
Aandoening
Atopic Dermatitis
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome parameter in this study is the change of SCORAD after 4 months of intervention.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
A positive effect of using test product with respect to the change of SCORAD after 4 months of intervention in subjects with atopic dermatitis.
Onderzoeksopzet
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).
Onderzoeksproduct en/of interventie
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.
Algemeen / deelnemers
Gerda van Wijhe
PO box 80141
Utrecht 3508TC
The Netherlands
+31 30 209 5000
clinicalresearch.nutricia@danone.com
Wetenschappers
Gerda van Wijhe
PO box 80141
Utrecht 3508TC
The Netherlands
+31 30 209 5000
clinicalresearch.nutricia@danone.com
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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.
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL3279 |
| NTR-old | NTR3447 |
| Ander register | Top Institute Pharma : SYN.3.C/A |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |