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Study to assess the effect of an added Synbiotic mixture on Atopic dermatitis in INfanTs.


- candidate number12398
- NTR NumberNTR3447
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-mei-2012
- Secondary IDsSYN.3.C/A Top Institute Pharma
- Public TitleStudy to assess the effect of an added Synbiotic mixture on Atopic dermatitis in INfanTs.
- Scientific TitleA 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.
- ACRONYMSAINT
- hypothesisA positive effect of using test product with respect to the change of SCORAD after 4 months of intervention in subjects with atopic dermatitis.
- Healt Condition(s) or Problem(s) studiedAtopic dermatitis
- Inclusion criteria1. 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 criteria1. 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.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 7-jun-2012
- planned closingdate31-mrt-2015
- Target number of participants144
- InterventionsDuration 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.
- Primary outcomeThe primary outcome parameter in this study is the change of SCORAD after 4 months of intervention.
- Secondary outcome1. 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.
- TimepointsScreening (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).
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESPhD. Jenny Cadée
- CONTACT for SCIENTIFIC QUERIES Anneke Rijnierse
- Sponsor/Initiator Top Institute Pharma (TI Pharma), Danone Research B.V., Academic Medical Center (AMC), Amsterdam, VU University Medical Center, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, University Medical Center Utrecht (UMCU), Wilhelmina Children's Hospital (WKZ)
- Funding
(Source(s) of Monetary or Material Support)
Top Institute Pharma (TI Pharma), Danone Research B.V. , Academic Medical Center (AMC), Utrecht Institute for Pharmaceutical Sciences, Utrecht University, VU University Medical Center, Wilhelmina Children's Hospital research fund
- PublicationsN/A
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD22-mei-2012 - 10-jun-2012


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