Clinical Trial: A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Prospective, Randomized, Double-Blind Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow
Brief Summary:
This study involves the use of 2 different Neocate formulas: a control formula called Neocate Infant and a test Neocate formula. These kinds of formulas are for use in children from birth to 8 months of age with Cow Milk Allergy (CMA), other food allergies, and other gastrointestinal disorders. The purpose of this study is to compare the control and test Neocate formulas for safety, tolerability, and effectiveness (in promoting growth) when used in subjects with CMA.
This study will also look at the test Neocate formula to see if it is hypoallergenic when used in subjects with CMA.
Detailed Summary:
Infants who qualify will begin a 7-day milk protein elimination diet that excludes all milk or products which contain milk. Parents will be asked to keep a food diary of everything the child eats during the week following the Screening Visit. During this week, the child can continue to drink their current hypoallergenic formula.
Subjects will be assessed at seven study visits at baseline, two weeks, four weeks and then monthly until the end of the study period, where the following will be assessed:
Study Visit 1 (Day -7): Baseline
This will be carried out at entry to the trial to collect baseline data; at this visit subjects will under go the following assessments:
Assess Patient suitability Obtain Informed Consent Obtain Subject number Perform physical exam and clinical assessment Medical history and assessment including SCORing Atopic Dermatitis assessment (SCORAD) Obtain weight, length and head circumference Collect a 9ml venous blood sample The following is to analysed by the central lab; Plasma total protein/albumin and prealbumin Blood urea nitrogen, electrolytes and creatinine Complete blood count with differential Alkaline phosphatase. Serum Iron, Total Iron Binding Capacity and Ferritin Plasma fatty acid analysis Provide stool lab kits and explain to parent/caregiver how to collect stool sample during the pre-evaluation week Provide one-week subject diary (Subject Diary 1) and instruct parent/caregiver on how to complete record, clinical symptoms and stool characteristics (frequency, consistency and color) in subject diary.
Provide the one-week Food Frequency Diary A and instruct the parent/caregiver on how to complete this assessment Provide information on following
Sponsor: Nutricia North America
Current Primary Outcome: The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. [ Time Frame: 4 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Nutricia North America
Dates:
Date Received: April 21, 2008
Date Started: March 2008
Date Completion:
Last Updated: March 5, 2015
Last Verified: October 2012
