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

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23678
Enrollment
144
Registered
2012-05-22
Start date
2012-06-07
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Atopic Dermatitis

Interventions

Duration of intervention: 4 months. Intervention group: Receiving an extensively hydrolyzed whey protein based infant formula with a synbiotic mixture (&#8805
500ml/day) for a period of 4 months. Control group: Receiving an extensively hydrolyzed whey protein based infant formula without a synbiotic mixture (&#8805
500ml/day) for a period of 4 months.

Sponsors

This clinical study will be performed within TOP Institute Pharma (project T1-501). Besides Danone Research, also the Academic Medical Center (AMC) Amsterdam, Wilhelmina Children's Hospital (WKZ) Utrecht, VU University Amsterdam, and the Utrecht Institute for Pharmaceutical Sciences (UIPS) will participate in the TOP Institute Pharma project. Danone Research shall take care of the Sponsor responsibilities as defined by ICH-GCP'.
Lead Sponsor

Eligibility

Inclusion criteria

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

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 outcomes

Primary

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

Secondary

MeasureTime frame
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.—

Contacts

Public ContactGerda van Wijhe

Clinical Research Operations

clinicalresearch.nutricia@danone.com+31 30 209 5000

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)