Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT00664768 |
| Other study ID # |
CT0131 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 2008 |
| Est. completion date |
July 2012 |
Study information
| Verified date |
December 2020 |
| Source |
Nutricia North America |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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
