Gastrointestinal TolerancePhase 3NCT00977964
Tolerance of Healthy Term Infants Fed Infant Formulas #3
A Phase 3 study testing Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B and Experimental milk protein infant formula Process C in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 15 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 six experimental milk protein-based powdered infant formulas. Read more about this study
- Who is it for?
- Ages Up to 8 daysHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tolerance
- What is being tested?
- Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B and Experimental milk protein infant formula Process C
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 15 sitesUnited States
- Study dates
- Sep 2009to Jan 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 Up to 8 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth.
- Infant's birth weight was > 2490 g (~5 lbs 8 oz.
- Infant is between 0 and 8 days of age at enrollment.
- Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
- 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, unless instructed otherwise by their healthcare professional.
Who cannot join
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics.
- Infant has received probiotics.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Kentucky Pediatric / Adult Research
Bardstown, Kentucky, 40004
Pediatric Associates of Mount Carmel, Inc
Cincinnati, Ohio, 45245
MetroHealth Medical Center
Cleveland, Ohio, 44109
North Georgia Clinical Research
Dalton, Georgia, 30721
Dayton Clinical Research
Dayton, Ohio, 45406
Alabama Clinical Therapeutics
Dothan, Alabama, 36305
Medical Associates Clinic, PC
Dubuque, Iowa, 52001
Ohio Pediatric Research Association, Inc.
Huber Heights, Ohio, 45424
Northpoint Pediatrics, LLC
Indianapolis, Indiana, 46038
The Jackson Clinic, PA
Jackson, Tennessee, 38305
Institute of Clinical Research
Mayfield Heights, Ohio, 44124
All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc
Plantation, Florida, 33324
Rockwood Clinic North - Pediatrics
Spokane, Washington, 99218
SCORE Physician Alliance, LLC
St. Petersburg, Florida, 33710
University of South Florida
Tampa, Florida, 33606
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 six experimental milk protein-based powdered infant formulas.
- Conditions
- Gastrointestinal Tolerance
- Being tested
- Experimental milk protein infant formula Process A, Experimental milk protein infant formula Process B, Experimental milk protein infant formula Process C, Experimental milk protein infant formula Process D, Experimental milk protein infant formula Process E
- Keywords
- Infant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental milk protein infant formula Process AOther
ad lib for 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process BOther
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process COther
ad lib from 1-8 days of age to 28 days of age
Experimental milk protein infant formula Process DOther
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process EOther
ad lib from 1-8 days of age until 28 days of age
Experimental milk protein infant formula Process FOther
ad lib from 1-8 days of age until 28 days of age
| Study group | Role | What they receive |
|---|---|---|
| Milk Based Protein Formula Process A | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process A |
| Milk Based Protein Formula Process B | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process B |
| Milk Based Protein Formula Process C | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process C |
| Milk Based Protein Formula Process D | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process D |
| Milk Based Protein Formula Process E | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process E |
| Milk Based Protein Formula Process F | Experimental | Not described Receives: Other: Experimental milk protein infant formula Process F |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary variable is Gastrointestinal tolerance.
Measured: 1-28 days of age
Secondary outcomes (1)
The secondary variables are additional measures of GI tolerance and parental feedback.
Measured: 1-28 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2010
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Nutrition
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Caude T Ashley, MD, Principal investigator, Alabama Clinical Therapeutics, LLCTerri L Ashmeade, MD, Principal investigator, USF Department of PediatricsJay Cohen, MD, Principal investigator, Discovery Clinical Research, Inc.Timothy Crum, MD, Principal investigator, Rockwood ClinicCole Ezeoke, MD, Principal investigator, North Georgia Clinical Research, White's PediatricsSharon Groh-Wargo, PhD, RD, LD, Principal investigator, MetroHealth Medical CenterJames Guerrieri, MD, Principal investigator, Institute of Clinical Research, LLCJames Hedrick, MD, Principal investigator, Kentucky Pediatric Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00977964
- Sponsor's protocol ID
- AK70
- Status last verified
- Nov 2010
- First submitted
- 15 Sep 2009
- Last updated
- 25 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
PubMed 37929831
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2010. 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
- NCT00977964
- Acronym / sponsor ID
- AK70
- Conditions
- Gastrointestinal Tolerance
- Keywords
- Infant
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- Abbott NutritionIndustry (pharma, biotech, devices)
- Study start
- Sep 2009
- Primary completion
- Jan 2010 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 16 Sep 2009 (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 six experimental milk protein-based powdered infant formulas.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Milk Based Protein Formula Process A | Experimental | Other: Experimental milk protein infant formula Process A |
| Milk Based Protein Formula Process B | Experimental | Other: Experimental milk protein infant formula Process B |
| Milk Based Protein Formula Process C | Experimental | Other: Experimental milk protein infant formula Process C |
| Milk Based Protein Formula Process D | Experimental | Other: Experimental milk protein infant formula Process D |
| Milk Based Protein Formula Process E | Experimental | Other: Experimental milk protein infant formula Process E |
| Milk Based Protein Formula Process F | Experimental | Other: Experimental milk protein infant formula Process F |
Who may qualify
- Ages
- Up to 8 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infant is judged to be in good health.
- Infant is a singleton from a full term birth.
- Infant's birth weight was > 2490 g (~5 lbs 8 oz.
- Infant is between 0 and 8 days of age at enrollment.
- Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled.
Key exclusion criteria (3 listed)
- An adverse maternal, fetal or infant medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
- Infant has been treated with antibiotics.
- Infant has received probiotics.
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 milk protein infant formula Process Aad lib for 1-8 days of age until 28 days of age | Other | Milk Based Protein Formula Process A |
| Experimental milk protein infant formula Process Bad lib from 1-8 days of age until 28 days of age | Other | Milk Based Protein Formula Process B |
| Experimental milk protein infant formula Process Cad lib from 1-8 days of age to 28 days of age | Other | Milk Based Protein Formula Process C |
| Experimental milk protein infant formula Process Dad lib from 1-8 days of age until 28 days of age | Other | Milk Based Protein Formula Process D |
| Experimental milk protein infant formula Process Ead lib from 1-8 days of age until 28 days of age | Other | Milk Based Protein Formula Process E |
| Experimental milk protein infant formula Process Fad lib from 1-8 days of age until 28 days of age | Other | Milk Based Protein Formula Process F |
Primary outcome
The primary variable is Gastrointestinal tolerance.
Time frame: 1-28 days of age
1 secondary outcome
The secondary variables are additional measures of GI tolerance and parental feedback.
Time frame: 1-28 days of age
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 25 Nov 2010.
- Derived from this study: PubMed 37929831Gonzalez-Garay AG, Serralde-Zuniga AE, Medina Vera I, Velasco Hidalgo L, Alonso Ocana MV. Higher versus lower protein intake in formula-fed term infants. Cochrane Database Syst Rev. 2023 Nov 6;11(11):CD013758. doi: 10.1002/14651858.CD013758.pub2.
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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.
Caude T Ashley, MD principal investigator
Alabama Clinical Therapeutics, LLC
Terri L Ashmeade, MD principal investigator
USF Department of Pediatrics
Jay Cohen, MD principal investigator
Discovery Clinical Research, Inc.
15 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 milk protein infant formula Process A, Experimental milk protein infant formula Process B and Experimental milk protein infant formula Process C in people with Gastrointestinal Tolerance, run by Abbott Nutrition at 15 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 3 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 25 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
The primary variable is Gastrointestinal tolerance. (time frame: 1-28 days of age). 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 NCT00977964, which also lists 1 linked publication.
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 25 Nov 2010.