NCT Number: NCT01181297
Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic
The purpose of this study is to confirm the hypoallergenicity of an extensively hydrolyzed formula with an added probiotic in children with documented milk allergy.
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Notify MeKey information
Conditions
Age range
Up to 14 year
Study type
Interventional
Phase
Not applicable
Primary location
Dept. of Paediatrics, Azienda Ospedaliera di Padova, Padova, Veneto, Italy
Who can participate
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- ≤14 years of age
- Essentially asymptomatic for a minimum of 7 days pre-challenge.
- Successful previous consumption of Extensively Hydrolyzed Formula within 1 week of study enrollment
- Medically documented allergy to cow's milk
Exclusion criteria
- Presence of underlying systemic disease or other illness
- Used Beta-blockers within 12-24 hours of challenges
- Use of short-acting antihistamines within 3 days
- Use of medium-acting antihistamines within 7 days
- Use of long-acting antihistamines within 6 weeks
- Use of oral steroid medication within 3 weeks
Treatment and study plan
Extensively Hydrolyzed Formula without a Probiotic
OtherSponsors and collaborators
Lead sponsor
Mead Johnson Nutrition
Industry
Registry information
Important dates
- Study start
- 2003
- Primary completion
- 2004
- Study completion
- 2004
- First posted
- Aug 13, 2010
- Registry last updated
- Aug 13, 2010
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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