Healthy Term InfantsPhase 3NCT01155414
Tolerance of Healthy Term Infants Fed Infant Formulas #4
A Phase 3 study testing Hydrolysate based infant formula, Investigational Infant Formula A and Investigational Infant Formula B in people with Healthy Term Infants, run by Abbott Nutrition at 10 sites in United States.
Trial summary
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula. Read more about this study
- Who is it for?
- Ages 1 day to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy Term Infants
- What is being tested?
- Hydrolysate based infant formula, Investigational Infant Formula A and Investigational Infant Formula B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 10 sitesUnited States
- Study dates
- Mar 2010to Jul 2010
- 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 1 day to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Singleton full term birth in good health
- Birth weight was > 2490 g.
- Between 0 and 8 days of age.
- Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
- Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
Who cannot join
- An adverse maternal, fetal or infant medical history and treatment with antibiotics
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35235
MetroHealth Medical Center
Cleveland, Ohio, 44109
University of Iowa
Coralville, Iowa, 52241
Alabama Clinical Therapeutics, LLC
Dothan, Alabama, 36305
Medical Associates Clinic, PC
Dubuque, Iowa, 52001
Pediatric Clinical Research Office
Hershey, Pennsylvania, 17033
Ohio Pediatric Research Association
Huber Heights, Ohio, 45424
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
SCORE Physician Alliance
St. Petersburg, Florida, 33710
About this study
Official title: Tolerance of Healthy Term Infants Fed Infant Formulas
The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
- Conditions
- Healthy Term Infants
- Being tested
- Hydrolysate based infant formula, Investigational Infant Formula A, Investigational Infant Formula B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydrolysate based infant formulaOther
Infant formula ad lib
Investigational Infant Formula AOther
Investigational infant formula ad lib
Investigational Infant Formula BOther
Investigational infant formula ad lib
| Study group | Role | What they receive |
|---|---|---|
| Investigational infant formula A | Experimental | Investigational Protein Hydrolysate formula Receives: Other: Investigational Infant Formula A |
| Hydrolysate based Infant Formula | Active comparator | Not described Receives: Other: Hydrolysate based infant formula |
| Investigational Infant Formula B | Experimental | Investigational Protein Hydrolysate Formula Receives: Other: Investigational Infant Formula B |
What is being measured
The primary outcome is the main question the study is designed to answer.
GI tolerance via stool consistency
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2010 (estimated)
- Study startMar 2010
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Term InfantsStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 168 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
- NCT01155414
- Sponsor's protocol ID
- AK75
- Status last verified
- Nov 2010
- First submitted
- 28 Jun 2010
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerance of Healthy Term Infants Fed Infant Formulas
- ClinicalTrials.gov ID
- NCT01155414
- Acronym / sponsor ID
- AK75
- Conditions
- Healthy Term Infants
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Mar 2010
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 1 Jul 2010 (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 primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to two experimental powdered formulas compared with a commercially available powdered formula.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Investigational infant formula A | Experimental | Other: Investigational Infant Formula AInvestigational Protein Hydrolysate formula |
| Hydrolysate based Infant Formula | Active comparator | Other: Hydrolysate based infant formula |
| Investigational Infant Formula B | Experimental | Other: Investigational Infant Formula BInvestigational Protein Hydrolysate Formula |
Who may qualify
- Ages
- 1 day to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Singleton full term birth in good health
- Birth weight was > 2490 g.
- Between 0 and 8 days of age.
- Infants using medications (including OTC such as Mylicon® for gas), home remedies (such as juice for constipation), herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled unless both the parent and the physician agree to discontinue these agents prior to enrollment.
- Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study, unless instructed otherwise by their healthcare professional.
Key exclusion criteria (1 listed)
- An adverse maternal, fetal or infant medical history and treatment with antibiotics
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 |
|---|---|---|
| Hydrolysate based infant formulaInfant formula ad lib | Other | Hydrolysate based Infant Formula |
| Investigational Infant Formula AInvestigational infant formula ad lib | Other | Investigational infant formula A |
| Investigational Infant Formula BInvestigational infant formula ad lib | Other | Investigational Infant Formula B |
Primary outcome
GI tolerance via stool consistency
Time frame: 28 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 1 Nov 2011.
Related trials for Healthy Term Infants
Active, not recruiting
Growth and Health Outcomes of a New Infant- and follow-on Formula for Healthy Term Infants.
Baby Formula, Growth Equivalence, Neurocognitive Development, Healthy Infants
Recruiting
Evaluation of the Nutritional Value of a New Hydrolysed Rice Protein-based Formula
Healthy Term Infants
Not yet recruitingPhase 3
A Clinical Trial on the Effect of Infant Formula Consumption on Growth, Immune Parameters, and Gut Health in Healthy Term Infants
Infant ALL
Active, not recruiting
Goat Infant Formula Feeding and Eczema (the GIraFFE Study)
Dermatitis, Atopic, Eczema, Infantile
Recruiting
Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Infant Nutritional Physiological Phenomena, Infant Formula
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
10 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 Hydrolysate based infant formula, Investigational Infant Formula A and Investigational Infant Formula B in people with Healthy Term Infants, run by Abbott Nutrition at 10 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 6 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 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
GI tolerance via stool consistency (time frame: 28 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 1 Nov 2011.