Double Blind Controlled Trial of an Extensively Hydrolyzed Formula With a Probiotic vs. an Extensively Hydrolyzed Formula Without a Probiotic

Mead Johnson Nutrition

Status: Completed

Conditions: Allergy

Treatments: Other: Extensively Hydrolyzed Formula with a Probiotic; Other: Extensively Hydrolyzed Formula without a Probiotic

Study type: Interventional

Funder types: Industry

Identifiers

NCT01181297

3369-2

Details and patient eligibility

About

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.

Sex

Ages: Under 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 2 patient groups, including a placebo group

Extensively Hydrolyzed Formula with a Probiotic

Experimental group

Description:

Extensively Hydrolyzed Formula with a Probiotic

Treatment:

Other: Extensively Hydrolyzed Formula with a Probiotic

Extensively Hydrolyzed Formula without a Probiotic

Placebo Comparator group

Treatment:

Other: Extensively Hydrolyzed Formula without a Probiotic