Ignite Creation Date:
2025-12-24 @ 5:57 PM
Ignite Modification Date:
2026-02-25 @ 8:58 PM
Study NCT ID:
NCT00664768
Status:
COMPLETED
Last Update Posted:
2020-12-09
First Post:
2008-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
Sponsor:
Nutricia North America
Organization:
Study Overview
Official Title:
A Prospective, Randomized, DB Controlled Study to Evaluate the Nutritional Safety (Growth) of an Amino Acid Based Formula With Prebiotics and Probiotics in Infants Diagnosed With Cow Milk Allergy, With or Without Other Food Allergies.
Status:
COMPLETED
Status Verified Date:
2020-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CMA
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.
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: