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OpenTrials
Completed

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.

Completed

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Key information

Age range

Up to 14 year

Study type

Interventional

Phase

Not applicable

Primary location

Dept. of Paediatrics, Azienda Ospedaliera di Padova, Padova, Veneto, Italy

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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 with a Probiotic

Other

Extensively Hydrolyzed Formula without a Probiotic

Other

Sponsors 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.

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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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