A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
Condition: Cow Milk Allergy
MeSH terms: Hypersensitivity; Milk Hypersensitivity
Study type: Interventional

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 description: 
      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 a milk protein exclusion diet, with
      or without the exclusion of other allergenic food proteins as advised by the subject's
      physician Record all concomitant medications taken within two weeks prior to the Baseline
      Visit

      Study Visit 2 (Day 0): Once subjects have completed the pre-evaluation period subjects will
      undergo the following assessment:

      Review Subject Diary 1 and Food Frequency Diary A, for study compliance Randomisation
      assignment to one of the two study formulas Perform physical exam and clinical assessment
      Obtain weight, length/height and head circumference Provide two-week subject diary (Subject
      Diary 2a) and instruct parent/caregiver on how to record clinical symptoms and stool
      characteristics in subject diary.

      Provide the one-week Food Frequency Diary B and instruct the parent/caregiver on how to
      complete this assessment Collect stool sample that was obtained in previous week at home

      Phone review (Day 7)

      Subjects will be reviewed at this time point by telephone to review if any clinical symptoms
      have occurred while ingesting study formula. If it is determined by the Principal
      Investigator that the subject has had any clinically significant reaction(s) to the study
      formula, the subject must return to the clinic for evaluation. Subjects will progress to
      Phase II and continue feeding with the formula they have consumed as part of the seven-day,
      post-challenge feeding period.

      Study Visit 3 (Day 14): Two weeks on formula

      Once subjects have been consuming their assigned formula for a two week period the following
      assessment will be carried out:

      Obtain weight, length and head circumference Collect Subject Diary 2a and Food Frequency
      Diary B Review of open feeding period and presence of any clinical symptoms Provide one-week
      subject diary (Subject Diary 3) to be completed the week before returning for Visit 4 and
      instruct parent/caregiver on how to record, clinical symptoms and stool characteristics in
      subject diary.

      Provide three-day Food Diary 1 to be completed the week before returning for visit 4 and
      instruct parent/caregiver on how to complete the food records Instruct parent to collect
      stool sample during the week before study Visit 4. Review study product requirement and
      dispense as necessary

      Study Visit 4 (Day 28): One month on formula

      Once subject have been consuming test formula for one month they will undergo the following
      assessment:

      Perform clinical assessment and SCORAD Obtain weight, length and head circumference Obtain
      stool sample collected by parent Collect and review Subject Diary 3 and Food Diary 1 Review
      study product requirement and dispense as necessary

      Study Visit 5 (Day 56): Two months on formula Obtain weight, length and head circumference
      Provide 3 day subject diary (Subject Diary 4) to be completed in the following week and
      instruct parent/caregiver on how to record clinical symptoms and stool characteristics in
      subject diary Provide three-day Food Diary 2 to be completed in the following week and
      instruct parent/caregiver on how to complete the food records Review study product
      requirement and dispense as necessary

      Study Visit 6 (Day 84): Three months on formula Obtain weight, length and head circumference
      Collect Subject Diary 4 and Food Diary 2 Provide one week subject diary (Subject Diary 5) to
      be completed in the week prior to the final study visit and instruct parent/caregiver on how
      to complete the food records, clinical symptoms and stool characteristics in subject diary
      Provide three-day Food Diary 3 to be completed in the week prior to the final study visit and
      instruct parent/caregiver on how to complete the food records Instruct parent to take stool
      sample during the week before the final study visit Review study product requirement and
      dispense as necessary

      Study Visit 7 (Day 112): Final visit - four months on formula or Early Termination Perform
      clinical assessment and SCORAD Obtain weight, length and head circumference Obtain stool
      sample collected by parent Collect and review Subject Diary 5 and Food Diary 3 Collect blood
      sample Ensure Parents/caregivers have returned all diaries to the appropriate clinician at
      each center Study personnel will review the forms with the parents/caregivers
      Parents/caregivers will return all partial and unopened cans of the test formula
    

Intervention name(s): Neocate Infant; new Neocate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): minimum of 8 fl. oz daily; minimum of 8 fl oz daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: hypoallergenicity; Cow Milk Allergy; DBPCFC; Stool microflora; Stool characteristics