Tolerance of Healthy Term Infants Fed Infant Formulas #4
This study has been completed.
Sponsor:
Abbott Nutrition
Information provided by (Responsible Party):
Abbott Nutrition
ClinicalTrials.gov Identifier:
NCT01155414
First received: June 28, 2010
Last updated: October 31, 2011
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 two experimental powdered formulas compared with a commercially available powdered formula.
| Condition | Intervention | Phase |
|---|---|---|
|
Healthy Term Infants |
Other: Hydrolysate based infant formula Other: Investigational Infant Formula A Other: Investigational Infant Formula B |
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:
- GI tolerance via stool consistency [ Time Frame: 28 days ] [ Designated as safety issue: No ]
| Enrollment: | 168 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2010 |
| Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Investigational infant formula A
Investigational Protein Hydrolysate formula
|
Other: Investigational Infant Formula A
Investigational infant formula ad lib
|
| Active Comparator: Hydrolysate based Infant Formula |
Other: Hydrolysate based infant formula
Infant formula ad lib
|
|
Experimental: Investigational Infant Formula B
Investigational Protein Hydrolysate Formula
|
Other: Investigational Infant Formula B
Investigational infant formula ad lib
|
Eligibility| Ages Eligible for Study: | up to 8 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
• An adverse maternal, fetal or infant medical history and treatment with antibiotics
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01155414
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics, LLC | |
| Birmingham, Alabama, United States, 35235 | |
| Alabama Clinical Therapeutics, LLC | |
| Dothan, Alabama, United States, 36305 | |
| United States, Florida | |
| SCORE Physician Alliance | |
| St. Petersburg, Florida, United States, 33710 | |
| United States, Iowa | |
| University of Iowa | |
| Coralville, Iowa, United States, 52241 | |
| Medical Associates Clinic, PC | |
| Dubuque, Iowa, United States, 52001 | |
| United States, Ohio | |
| MetroHealth Medical Center | |
| Cleveland, Ohio, United States, 44109 | |
| Ohio Pediatric Research Association | |
| Huber Heights, Ohio, United States, 45424 | |
| Institute of Clinical Research | |
| Mayfield Heights, Ohio, United States, 44124 | |
| United States, Pennsylvania | |
| Pediatric Clinical Research Office | |
| Hershey, Pennsylvania, United States, 17033 | |
| United States, Tennessee | |
| The Jackson Clinic, PA | |
| Jackson, Tennessee, United States, 38305 | |
Sponsors and Collaborators
Abbott Nutrition
Investigators
| Study Chair: | Marlene Borschel, PhD | Abbott Nutrition |
More Information
No publications provided
| Responsible Party: | Abbott Nutrition |
| ClinicalTrials.gov Identifier: | NCT01155414 History of Changes |
| Other Study ID Numbers: | AK75 |
| Study First Received: | June 28, 2010 |
| Last Updated: | October 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
ClinicalTrials.gov processed this record on May 19, 2013