Tolerance of Healthy Term Infants Fed Infant Formulas #3
This study has been completed.
Sponsor:
Abbott Nutrition
Information provided by:
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT00977964
First received: September 15, 2009
Last updated: November 24, 2010
Last verified: November 2010
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Gastrointestinal Tolerance |
Other: Experimental milk protein infant formula Process A Other: Experimental milk protein infant formula Process B Other: Experimental milk protein infant formula Process C Other: Experimental milk protein infant formula Process D Other: Experimental milk protein infant formula Process E Other: Experimental milk protein infant formula Process F |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Tolerance of Healthy Term Infants Fed Infant Formulas |
Resource links provided by NLM:
Further study details as provided by Abbott Nutrition:
Primary Outcome Measures:
- The primary variable is Gastrointestinal tolerance. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- The secondary variables are additional measures of GI tolerance and parental feedback. [ Time Frame: 1-28 days of age ] [ Designated as safety issue: No ]
| Enrollment: | 270 |
| Study Start Date: | September 2009 |
| Study Completion Date: | January 2010 |
| Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Milk Based Protein Formula Process A |
Other: Experimental milk protein infant formula Process A
ad lib for 1-8 days of age until 28 days of age
|
| Experimental: Milk Based Protein Formula Process B |
Other: Experimental milk protein infant formula Process B
ad lib from 1-8 days of age until 28 days of age
|
| Experimental: Milk Based Protein Formula Process C |
Other: Experimental milk protein infant formula Process C
ad lib from 1-8 days of age to 28 days of age
|
| Experimental: Milk Based Protein Formula Process D |
Other: Experimental milk protein infant formula Process D
ad lib from 1-8 days of age until 28 days of age
|
| Experimental: Milk Based Protein Formula Process E |
Other: Experimental milk protein infant formula Process E
ad lib from 1-8 days of age until 28 days of age
|
| Experimental: Milk Based Protein Formula Process F |
Other: Experimental milk protein infant formula Process F
ad lib from 1-8 days of age until 28 days of age
|
Eligibility| Ages Eligible for Study: | up to 8 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977964
Please refer to this study by its ClinicalTrials.gov identifier: NCT00977964
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics | |
| Dothan, Alabama, United States, 36305 | |
| United States, Florida | |
| All Women's Heatlthcare of West Broward, Inc: Discovery Clinical Research, Inc | |
| Plantation, Florida, United States, 33324 | |
| SCORE Physician Alliance, LLC | |
| St. Petersburg, Florida, United States, 33710 | |
| University of South Florida | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| North Georgia Clinical Research | |
| Dalton, Georgia, United States, 30721 | |
| United States, Indiana | |
| Northpoint Pediatrics, LLC | |
| Indianapolis, Indiana, United States, 46038 | |
| United States, Iowa | |
| Medical Associates Clinic, PC | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Kentucky | |
| Kentucky Pediatric / Adult Research | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Ohio | |
| Pediatric Associates of Mount Carmel, Inc | |
| Cincinnati, Ohio, United States, 45245 | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Dayton Clinical Research | |
| Dayton, Ohio, United States, 45406 | |
| Ohio Pediatric Research Association, Inc. | |
| Huber Heights, Ohio, United States, 45424 | |
| Institute of Clinical Research | |
| Mayfield Heights, Ohio, United States, 44124 | |
| United States, Tennessee | |
| The Jackson Clinic, PA | |
| Jackson, Tennessee, United States, 38305 | |
| United States, Washington | |
| Rockwood Clinic North - Pediatrics | |
| Spokane, Washington, United States, 99218 | |
Sponsors and Collaborators
Abbott Nutrition
Investigators
| Principal Investigator: | Caude T Ashley, MD | Alabama Clinical Therapeutics, LLC | |
| Principal Investigator: | Terri L Ashmeade, MD | USF Department of Pediatrics | |
| Principal Investigator: | Jay Cohen, MD | Discovery Clinical Research, Inc. | |
| Principal Investigator: | Timothy Crum, MD | Rockwood Clinic | |
| Principal Investigator: | Cole Ezeoke, MD | North Georgia Clinical Research, White's Pediatrics | |
| Principal Investigator: | Sharon Groh-Wargo, PhD, RD, LD | MetroHealth Medical Center | |
| Principal Investigator: | James Guerrieri, MD | Institute of Clinical Research, LLC | |
| Principal Investigator: | James Hedrick, MD | Kentucky Pediatric Research | |
| Principal Investigator: | Jeffrey Hirschfield, MD | SCORE Physician Alliance, LLC | |
| Principal Investigator: | Kevin Mullen, MD | Medical Associates Clinic, PC | |
| Principal Investigator: | Chris Peltier, MD | Pediatric Associates of Mount Carmel, Inc. | |
| Principal Investigator: | Martin J Schear, MD | Dayton Clinical Research | |
| Principal Investigator: | Julie Shepard, MD | Ohio Pediatric Research Association | |
| Principal Investigator: | William Stepp, MD | Sarah Cannon Research Institute, LLC | |
| Principal Investigator: | L Louise Tetrick, MD | Northpoint Pediatrics |
More Information
No publications provided
| Responsible Party: | Bobbie L Swearengin, RN, Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT00977964 History of Changes |
| Other Study ID Numbers: | AK70 |
| Study First Received: | September 15, 2009 |
| Last Updated: | November 24, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Abbott Nutrition:
|
Infant |
ClinicalTrials.gov processed this record on March 01, 2015