Protein IntoleranceNCT03884309
Evaluation of Infants Fed an Extensively Hydrolyzed Infant Formula
A study testing Experimental Hydrolyzed Protein Infant Formula in people with Protein Intolerance, run by Abbott Nutrition at 6 sites in United States.
Trial summary
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population. Read more about this study
- Who is it for?
- Ages Up to 60 days
- Conditions the study is for
- Protein Intolerance
- What is being tested?
- Experimental Hydrolyzed Protein Infant Formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 6 sitesUnited States
- Study dates
- 25 Mar 2019to 7 Jan 2020
- 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 Up to 60 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
- Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Who cannot join
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
- Participant is receiving oral or inhaled steroids.
- Participant participates in another study that has not been approved as a concomitant study.
- Participant has an allergy or intolerance to any ingredient in the study product.
- Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Paramount Research Solutions
College Park, Georgia, 30349
Ventavia Research Group, LLC
Houston, Texas, 77008
Midwest Children's Health Research Institute
Lincoln, Nebraska, 68522
DCOL Center for Clinical Research
Longview, Texas, 75605
Memphis & Shelby County Pediatric Group
Memphis, Tennessee, 38116
Michael W. Simon, M.D., PSC
Nicholasville, Kentucky, 40356
About this study
Official title: Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides
This is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
- Conditions
- Protein Intolerance
- Being tested
- Experimental Hydrolyzed Protein Infant Formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Hydrolyzed Protein Infant FormulaOther
fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Experimental Hydrolyzed Protein Infant Formula | Experimental | hydrolyzed protein infant formula powder in cans Receives: Other: Experimental Hydrolyzed Protein Infant Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight for Age
Change in weight for age z-score
Measured: Study Day 1 to Study Day 60
Secondary outcomes (3)
Gastrointestinal Tolerance
Parent completed diary questions
Measured: Study Day 1 to Study Day 60
Length
Gain measured in cm
Measured: Study Day 1 to Study Day 60
Head Circumference
Gain measured in cm
Measured: Study Day 1 to Study Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study start25 Mar 2019
- Primary completion7 Jan 2020
- Study completion7 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Protein IntoleranceStudies 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Barbara Marriage, PhD, RD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884309
- Sponsor's protocol ID
- AL32
- Status last verified
- Jan 2020
- First submitted
- 18 Mar 2019
- Last updated
- 5 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance, Compliance and Growth of Infants Fed an Extensively Hydrolyzed Infant Formula With Added Human Milk Oligosaccharides
- ClinicalTrials.gov ID
- NCT03884309
- Acronym / sponsor ID
- AL32
- Conditions
- Protein Intolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2019 (actual)
- Primary completion
- 7 Jan 2020 (actual)
- Study completion
- 7 Jan 2020 (actual)
- First posted
- 21 Mar 2019 (actual)
- 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 is a single group, non-randomized, multicenter study to assess the effects of a hypoallergenic casein hydrolysate powdered infant formula on gastrointestinal (GI) tolerance, growth and compliance in an intended use infant population.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Hydrolyzed Protein Infant Formula | Experimental | Other: Experimental Hydrolyzed Protein Infant Formulahydrolyzed protein infant formula powder in cans |
Who may qualify
- Ages
- Up to 60 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant is presently consuming an extensively hydrolyzed infant formula (EHF) for persistent feeding intolerance symptoms, symptoms of suspected food protein (milk and/or soy) sensitivity, or other conditions where EHF is deemed an appropriate feeding.
- Parent(s) of infants confirm their intention not to administer prescription medications, over the counter medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study.
- Parent(s) confirm their intention not to administer vitamins, minerals (with the exception of Vitamin D supplements), solid foods or juices to their infant from enrollment through the duration of the study.
- Participant's parent(s) or a legally authorized representative (LAR) has voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.
Key exclusion criteria (5 listed)
- An adverse maternal, fetal or participant medical history that is thought by the investigator to have potential for effects on growth, and/or development.
- Participant is receiving oral or inhaled steroids.
- Participant participates in another study that has not been approved as a concomitant study.
- Participant has an allergy or intolerance to any ingredient in the study product.
- Participant has been treated with antibiotics or other medications that in the opinion of the PI may affect growth, GI tolerance and/or development, within 2 weeks prior to enrollment.
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 |
|---|---|---|
| Experimental Hydrolyzed Protein Infant Formulafed ad libitum | Other | Experimental Hydrolyzed Protein Infant Formula |
Primary outcome
Weight for Age
Time frame: Study Day 1 to Study Day 60
Change in weight for age z-score
3 secondary outcomes
Gastrointestinal Tolerance
Time frame: Study Day 1 to Study Day 60
Length
Time frame: Study Day 1 to Study Day 60
Head Circumference
Time frame: Study Day 1 to Study Day 60
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 5 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 Marriage, PhD, RD study chair
Abbott Nutrition
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Hydrolyzed Protein Infant Formula in people with Protein Intolerance, run by Abbott Nutrition at 6 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 5 inclusion and 5 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 5 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Weight for Age (time frame: Study Day 1 to Study Day 60). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Feb 2020.