Cow Milk AllergyCMANCT00664768
A Growth and Hypoallergenicity Study of a New Formula for Infants With Cow Milk Allergy
A study testing Neocate Infant and new Neocate in people with Cow Milk Allergy, run by Nutricia North America at 22 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 8 months
- Conditions the study is for
- Cow Milk Allergy
- What is being tested?
- Neocate Infant and new Neocate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 22 sitesUnited States
- Study dates
- Mar 2008to Jul 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 8 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
- Positive double-blind placebo controlled food challenge with cow milk
- A confirmed history of acute severe reaction after isolated accidental ingestion with a positive test result for IgE antibody
- Confirmed history of a reaction to cow milk protein with CM-specific IgE of >15kU/L for children over two years and > 5kU/L for children under two years.
- Confirmed clinical history of a reaction to cow milk protein with a positive skin prick test with a resulting wheal diameter greater or equal to 3mm.
- No confirmed clinical history of a reaction to cow milk protein subjects with a positive skin prick test with a resulting wheal diameter greater or equal to 8mm for children over 2 years and greater or equal to 6mm for children under 2 years.
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- For children with an Allergic Eosinophilic Gastroenteritis (AEG), documentation of eosinophilic infiltration and resolution of symptoms on a diet that restricted cow milk (and other foods) with reoccurrence after re-administration of cow milk.
- Written informed consent / ability to give informed consent.
- These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,
Who cannot join
- All subjects
- Infants <5lb 8oz at birth
- Infants < 37 weeks gestation
- Infants with severe concurrent illness or major congenital malformations
- Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
- Unable to adhere to protocol instructions due to non compliance of parent or caregiver
Show all 12Show fewer
- Investigator's uncertainty about the willingness or ability of the patient to comply with the protocol requirements
- Participation in any other studies involving investigational products concomitantly or within twenty eight days prior to entry into the study
- An infant of any personnel connected with the study
- Infants whose parent/caregiver is younger than the legal age of consent
- For these subjects the dietary consumption of other sources of prebiotics or probiotics is prohibited two weeks prior to inclusion in the study and during the study period.
- These subjects must not have received systemic antibiotics in the previous two weeks prior to entry into the study.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Asheboro Research Associates
Asheboro, North Carolina, 27203
Children's Investigational Research Program, LLC (CHIRP)
Bentonville, Arkansas, 72712
Craig A. Spiegel, M.D.
Bridgeton, Missouri, 63044
PI-Coor Clinical Research, LLC
Burke, Virginia, 22015
Pendleton Pediatrics
Chandler, Arizona, 85224
Duke University
Durham, North Carolina, 27710
Alzein Pediatrics
Evergreen Park, Illinois, 60805
Pediatrics, PLLC
Holly Springs, North Carolina, 27540
Nemours Children's Clinic
Jacksonville, Florida, 32207
Children's Hospital, LA
Los Angeles, California, 90027
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095
John Panuto, M.D.
Middleburg Heights, Ohio, 44130
Weill Cornell Medical College
New York, New York, 10021
Meridian Clinical Research, LLC
Omaha, Nebraska, 68134
Rosario B. Retino, MD, Inc
Ontario, California, 91762
Choc Psf, Amc
Orange, California, 92868
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Childrens Hospital of Pittsburgh
Pittsburgh, Pennsylvania, 15213
Virginia Commonwealth University
Richmond, Virginia, 23219
Regional Research Specialists, LLC
Shreveport, Louisiana, 71106
Visions Clinical Research - Tucson
Tucson, Arizona, 85712
Advanced Pediatrics
Vienna, Virginia, 22180
About this study
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.
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.
Read the 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
- Conditions
- Cow Milk Allergy
- Being tested
- Neocate Infant, new Neocate
- Keywords
- hypoallergenicity, Cow Milk Allergy, DBPCFC, Stool microflora, Stool characteristics
- Medical subject headings
- Milk Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neocate InfantDietary supplement
minimum of 8 fl. oz daily
new NeocateDietary supplement
minimum of 8 fl oz daily
| Study group | Role | What they receive |
|---|---|---|
| New Neocate | Experimental | new Neocate Receives: Dietary Supplement: new Neocate |
| Neocate Infant | Active comparator | Neocate Infant formula Receives: Dietary Supplement: Neocate Infant |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. Length and head circumference measures will also be collected and analysed. Both the growth velocities of the group as a whole (cross-sectional group data) and individuals (longitudinal individual data) will be reviewed and analysed. In assessing group data, comparisons of increments per unit of time will be made. Due to the varying ages of the subjects recruited to the study, growth measures will be concerted to z-scores using an appropriate reference population to allow a meaningful comparison of the ability of the formulas to promote growth. In assessing the growth of individual infants, data will be plotted on National Centre for Health Statistics (NCHS) growth charts and assessed qualitatively.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cow Milk AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nutricia North America
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutricia Liverpool, Danone Institute International
- Responsible party
- Sponsor
- Investigators
- Barbara Mourmans, Study director, Study Mgr Nutricia Research - Centre for Specialised Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00664768
- Sponsor's protocol ID
- CT0131
- Acronym
- CMA
- Status last verified
- Dec 2020
- First submitted
- 21 Apr 2008
- Last updated
- 9 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
PubMed 33006765Harvey BM, Eussen SRBM, van Helvoort A, Harthoorn LF. Cow's Milk Allergic Infants on Elemental Formula Maintain Adequate Mineral Status Despite Using Acid-suppressive Drugs. J Pediatr Gastroenterol Nutr. 2019 Nov;69(5):e147-e148. doi: 10.1097/MPG.0000000000002469. No abstract available.
PubMed 31425366Burks AW, Harthoorn LF, Van Ampting MT, Oude Nijhuis MM, Langford JE, Wopereis H, Goldberg SB, Ong PY, Essink BJ, Scott RB, Harvey BM. Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. Pediatr Allergy Immunol. 2015 Jun;26(4):316-22. doi: 10.1111/pai.12390.
PubMed 25845680
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00664768
- Acronym / sponsor ID
- CMA / CT0131
- Conditions
- Cow Milk Allergy
- Keywords
- hypoallergenicity, Cow Milk Allergy, DBPCFC, Stool microflora, Stool characteristics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Nutricia North AmericaIndustry (pharma, biotech, devices)
- Collaborators
- Nutricia Liverpool, Danone Institute International
- Study start
- Mar 2008
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 23 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| New Neocate | Experimental | Dietary Supplement: new Neocatenew Neocate |
| Neocate Infant | Active comparator | Dietary Supplement: Neocate InfantNeocate Infant formula |
Who may qualify
- Ages
- 1 day to 8 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Subjects aged from birth to 8 months old with documented allergy to cow milk protein are eligible to enter the study. Subjects with other IgE or non IgE mediated allergies to food in addition to milk protein (e.g. multiple food allergy or an eosinophilic disorder) are also eligible to enter the study. However all subjects must have a confirmed allergy to milk confirmed by one of the following criteria, within two months prior to the baseline visit:
- Written informed consent / ability to give informed consent.
- These subjects are expected to consume a minimum intake of test formula to ensure an average daily intake, which provides at least 50% of their daily energy requirements,
Key exclusion criteria (12 listed)
- All subjects
- Infants <5lb 8oz at birth
- Infants < 37 weeks gestation
- Infants with severe concurrent illness or major congenital malformations
- Suspected or documented systemic or congenital infections (e.g. human immunodeficiency virus)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neocate Infantminimum of 8 fl. oz daily | Dietary supplement | Neocate Infant |
| new Neocateminimum of 8 fl oz daily | Dietary supplement | New Neocate |
Primary outcome
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period.
Time frame: 4 months
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. Length and head circumference measures will also be collected and analysed. Both the growth velocities of the group as a whole (cross-sectional group data) and individuals (longitudinal individual data) will be reviewed and analysed. In assessing group data, comparisons of increments per unit of time will be made. Due to the varying ages of the subjects recruited to the study, growth measures will be concerted to z-scores using an appropriate reference population to allow a meaningful comparison of the ability of the formulas to promote growth. In assessing the growth of individual infants, data will be plotted on National Centre for Health Statistics (NCHS) growth charts and assessed qualitatively.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2020.
- Derived from this study: PubMed 33006765Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.
- Derived from this study: PubMed 31425366Harvey BM, Eussen SRBM, van Helvoort A, Harthoorn LF. Cow's Milk Allergic Infants on Elemental Formula Maintain Adequate Mineral Status Despite Using Acid-suppressive Drugs. J Pediatr Gastroenterol Nutr. 2019 Nov;69(5):e147-e148. doi: 10.1097/MPG.0000000000002469. No abstract available.
- Derived from this study: PubMed 25845680Burks AW, Harthoorn LF, Van Ampting MT, Oude Nijhuis MM, Langford JE, Wopereis H, Goldberg SB, Ong PY, Essink BJ, Scott RB, Harvey BM. Synbiotics-supplemented amino acid-based formula supports adequate growth in cow's milk allergic infants. Pediatr Allergy Immunol. 2015 Jun;26(4):316-22. doi: 10.1111/pai.12390.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Mourmans study director
Study Mgr Nutricia Research - Centre for Specialised Nutrition
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neocate Infant and new Neocate in people with Cow Milk Allergy, run by Nutricia North America at 22 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint is attained growth (i.e. incremental gains in weight) over the study period. (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00664768, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2020.