Gastrointestinal ToleranceNCT05369494
Infants Fed a Hydrolyzed Infant Formula
A study testing Hydrolyzed protein infant formula with oligosaccharides in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 7 sites in United States.
Trial summary
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants. Read more about this study
- Who is it for?
- Ages 0 to 90 days
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Hydrolyzed protein infant formula with oligosaccharides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 7 sitesUnited States
- Study dates
- 7 May 2022to 18 Nov 2023
- 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 0 to 90 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant is 0 to 90 days of age at enrollment.
- Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
- Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
- 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 solid foods or juices to their infant from enrollment through the duration of the study
- Parent(s) confirm their intention not to administer vitamin or mineral supplements (with the exception of Vitamin D supplements) to their infant from enrollment through the duration of the study, unless instructed otherwise by their healthcare professional
- Infant's parent(s) or a 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
- Awareness of a positive drug screen in the mother or participant
- Suspected maternal substance abuse including alcohol
- Participation in another study that has not been approved as a concomitant study by AN
- Participant is receiving oral or inhaled steroids
- Participant has an allergy or intolerance to any ingredient in the study product, as reported by the parent
- Participant has received an amino acid-based formula
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Meridian Clinical Research 3357
Charleston, South Carolina, 29407
Javara Inc.
Fayetteville, Georgia, 72703
Gentle Pediatrics
Houston, Texas, 77084
Meridian Clinical Research 3259
Macon, Georgia, 31210
AdventHealth Medical Group Pediatrics
Orange City, Florida, 32763
Springs Medical Research
Owensboro, Kentucky, 42303
Meridian Clinical Research, LLC
Washington D.C., District of Columbia, 20016
About this study
Official title: Tolerance of Infants Fed a Hydrolyzed Infant Formula
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Hydrolyzed protein infant formula with oligosaccharides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolyzed protein infant formula with oligosaccharidesOther
Hydrolyzed protein infant formula with oligosaccharides
| Study group | Role | What they receive |
|---|---|---|
| Experimental Product | Experimental | Infant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz. Receives: Other: Hydrolyzed protein infant formula with oligosaccharides |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Maintenance
Change in weight for age z-score
Measured: Study Day1 to Study Day 28
Secondary outcomes (3)
Gastrointestinal Tolerance
Parent completed diary
Measured: Study Day1 to Study Day 28
Weight
Weight gain per day in grams
Measured: Study Day1 to Study Day 28
Length
Length gain per day in cm
Measured: Study Day1 to Study Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2022
- Study start7 May 2022
- Primary completion23 Jun 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal ToleranceStudies 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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carlett Ramirez, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05369494
- Sponsor's protocol ID
- AL49
- Status last verified
- Apr 2024
- First submitted
- 3 May 2022
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Infants Fed a Hydrolyzed Infant Formula
- ClinicalTrials.gov ID
- NCT05369494
- Acronym / sponsor ID
- AL49
- Conditions
- Gastrointestinal Tolerance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- 7 May 2022 (actual)
- Primary completion
- 23 Jun 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 11 May 2022 (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.
The purpose of this non-randomized, multi-center study is to evaluate the growth, tolerance and compliance of an extensively hydrolyzed infant formula in an intended use population of infants.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental Product | Experimental | Other: Hydrolyzed protein infant formula with oligosaccharidesInfant formula product consumed ad libitum as instructed for approximately 28 days; Powder formula mixed to 20 kcal/fl. oz. |
Who may qualify
- Ages
- 0 to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Infant is 0 to 90 days of age at enrollment.
- Formula-fed Infant who is either experiencing persistent feeding intolerance, symptoms of suspected food protein allergy or currently consuming an extensively hydrolyzed formula (EHF) for symptoms of suspected food protein allergy, persistent feeding intolerance symptoms or other conditions where EHF is deemed an appropriate feeding by their health care professional
- Parent(s) of infants confirm their intention not to administer prescription medications, OTC medications, home remedies, prebiotics, probiotics, herbal preparations or rehydration fluids that might affect GI tolerance, unless their infants are currently consuming and have been directed by their healthcare professional to continue their use during the study
- 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 solid foods or juices to their infant from enrollment through the duration of the study
Key exclusion criteria (7 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
- Awareness of a positive drug screen in the mother or participant
- Suspected maternal substance abuse including alcohol
- Participation in another study that has not been approved as a concomitant study by AN
- Participant is receiving oral or inhaled steroids
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 |
|---|---|---|
| Hydrolyzed protein infant formula with oligosaccharidesHydrolyzed protein infant formula with oligosaccharides | Other | Experimental Product |
Primary outcome
Weight Maintenance
Time frame: Study Day1 to Study Day 28
Change in weight for age z-score
3 secondary outcomes
Gastrointestinal Tolerance
Time frame: Study Day1 to Study Day 28
Weight
Time frame: Study Day1 to Study Day 28
Length
Time frame: Study Day1 to Study Day 28
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 1 May 2024.
- Individual participant dataSharing planned: No
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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.
Carlett Ramirez study chair
Abbott Nutrition
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hydrolyzed protein infant formula with oligosaccharides in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 7 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 7 inclusion and 7 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 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 Maintenance (time frame: Study Day1 to Study Day 28). 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 1 May 2024.