InfantPhase 3NCT01573871
Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula
A Phase 3 study testing Experimental Hydrolyzed infant formula in people with Infant and Gastrointestinal Intolerance, run by Abbott Nutrition at 3 sites in United States.
Trial summary
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula. Read more about this study
- Who is it for?
- Ages Up to 180 days
- Conditions the study is for
- Infant, Gastrointestinal Intolerance
- What is being tested?
- Experimental Hydrolyzed infant formula
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2012to Sep 2012
- Phase
- Phase 3
- 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 180 days
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infant is 0 to 180 days of age
- Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
- Infant has not consumed an extensively hydrolyzed infant formula
- Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
- Infant is not receiving steroids.
- 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 through the duration of the study.
- Parent(s) confirm their intention not to administer vitamin or mineral during the study
Who cannot join
- Participation in another study
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Metro-Health Medical Center
Cleveland, Ohio, 44109
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424
Northpoint Pediatrics
Indianapolis, Indiana, 46038
About this study
Official title: Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
- Conditions
- Infant, Gastrointestinal Intolerance
- Being tested
- Experimental Hydrolyzed infant formula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental Hydrolyzed infant formulaOther
Experimental hydrolyzed infant formula to be fed ad libitum
| Study group | Role | What they receive |
|---|---|---|
| Hydrolyzed infant formula | Experimental | Hydrolyzed infant formula to be fed ad libitum Receives: Other: Experimental Hydrolyzed infant formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight maintenance
Measured: 14 days
Secondary outcomes (1)
Formula volume intake
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2012 (estimated)
- Study startFeb 2012
- Primary completionSep 2012
- Study completionSep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfantStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Marlene Borschel, PhD, Study chair, Abbott Nutrition
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01573871
- Sponsor's protocol ID
- AK94
- Status last verified
- Feb 2013
- First submitted
- 6 Apr 2012
- Last updated
- 15 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula
- ClinicalTrials.gov ID
- NCT01573871
- Acronym / sponsor ID
- AK94
- Conditions
- Infant, Gastrointestinal Intolerance
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Sep 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 10 Apr 2012 (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.
The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hydrolyzed infant formula | Experimental | Other: Experimental Hydrolyzed infant formulaHydrolyzed infant formula to be fed ad libitum |
Who may qualify
- Ages
- Up to 180 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Infant is 0 to 180 days of age
- Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
- Infant has not consumed an extensively hydrolyzed infant formula
- Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
- Infant is not receiving steroids.
Key exclusion criteria (1 listed)
- Participation in another study
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 infant formulaExperimental hydrolyzed infant formula to be fed ad libitum | Other | Hydrolyzed infant formula |
Primary outcome
Weight maintenance
Time frame: 14 days
1 secondary outcome
Formula volume intake
Time frame: 14 days
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 15 Feb 2013.
Related trials for Infant
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
RecruitingObservational study
Defining the Natural History of Squamous Cell Carcinoma in Fanconi Anemia
Fanconi Anemia, Inherited Bone Marrow Failure Syndrome
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.
Marlene Borschel, PhD study chair
Abbott Nutrition
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Experimental Hydrolyzed infant formula in people with Infant and Gastrointestinal Intolerance, run by Abbott Nutrition at 3 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 8 inclusion and 1 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 15 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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: 14 days). 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 15 Feb 2013.