Clinical trial NCT02401217: Tolerance of Healthy Infants Fed Infant Formulas
Official title: Tolerance of Healthy Infants Fed Infant Formulas
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tolerance
Lead sponsor: Abbott Nutrition
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 126
Sex: ALL
Maximum age (years): 30
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The primary objective of this study is to assess the comparative gastrointestinal tolerance of normal term infants to two experimental milk-based powdered formulas compared with a standard milk-based powdered formula.


Eligibility criteria: Inclusion Criteria:

* Singleton from a full term birth with a gestational age of 37-42 weeks.
* Birth weight was \> 2490 g (\~5 lbs 8 oz).
* Age between 0 and 30 days at enrollment.
* Agreement to discontinue the use of medications (including over the counter \[OTC\], such as Mylicon® for gas), home remedies, herbal preparations or rehydration fluids that might affect GI tolerance for the duration of the study.
* Intention to feed the infant the study product as the sole source of nutrition for the duration of the study.
* Intention not to administer vitamin (other than Vitamin D) or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.
* Voluntarily signed and dated an informed consent form (ICF) approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB) and provided Health Insurance Portability and Accountability Act (HIPAA) (or other applicable privacy regulation) authorization prior to any participation in the study.

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 treated with antibiotics.
* Participation in another study that has not been approved as a concomitant study by AN.

Primary outcomes:
measure: Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
timeFrame: Change from Study Day 1 to Study Day 15
Secondary outcomes:
measure: Mean Percentage of stools representing each stool consistency and color using parent reported diaries
timeFrame: Change from Study Day 1 to Study Day 15
measure: Mean predominant stool consistency and color measured using parent reported diaries
timeFrame: Change from Study Day 1 to Study Day 15
measure: Average number of stools per day measured using parent reported diaries
timeFrame: Change from Study Day 1 to Study Day 15
measure: Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.
timeFrame: Change from Study Day 1 to Study Day 15
measure: Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires
timeFrame: Change from Study Day 1 to Study Day 15
measure: Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.
timeFrame: Change from Study Day 1 to Study Day 15
Other outcomes:
Locations:
city: Tucson
country: United States
facility: W.O.M.B Watching Over Mothers and Babies
state: Arizona
city: St. Petersburg
country: United States
facility: SCORE Physician Alliance LLC
state: Florida
city: Asheboro
country: United States
facility: White Oak Family Physicians DBA/Asheboro Research Associates
state: North Carolina
city: Mayfield Heights
country: United States
facility: Institute of Clinical Research, LLC
state: Ohio
city: Middleburg Heights
country: United States
facility: The Cleveland Pediatric Research Center, LLC
state: Ohio
city: Layton
country: United States
facility: Tanner Memorial Clinic
state: Utah
Study officials:
affiliation: Abbott Nutrition
name: Marlene Borschel, PhD, RD
role: STUDY_CHAIR
References: