Gastrointestinal Tolerance
Conditions
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.
Interventions
OTHERPhase 1- Arm 1 Infant Formula
Powder infant formula
OTHERPhase 2- Arm 2 Infant Formula
Powder infant formula
OTHERPhase 2- Arm 3 Infant Formula
Powder infant formula
Sponsors
Abbott Nutrition
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 30 Days
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries | Change from Study Day 1 to Study Day 15 | MRSC will be calculated from data recorded on daily stool records during the study. Stool consistencies will be assigned the following: 1=watery, 2=loose/mushy, 3=soft, 4=formed, 5=hard. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean Percentage of stools representing each stool consistency and color using parent reported diaries | Change from Study Day 1 to Study Day 15 | Mean percentage of each recorded stool consistency (watery, loose/mushy, soft, formed, hard) and stool color (yellow, brown, green, black) will be calculated for each infant and then used to calculate for each group from daily data recorded on daily stool records during the study. |
| Mean predominant stool consistency and color measured using parent reported diaries | Change from Study Day 1 to Study Day 15 | Mean predominant stool consistency and color for each infant calculated from data recorded on daily stool records during the study will be used to calculate the mean predominant stool consistency and color for each group. |
| Average number of stools per day measured using parent reported diaries | Change from Study Day 1 to Study Day 15 | Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study. |
| Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries. | Change from Study Day 1 to Study Day 15 | Mean percentages of feedings associated with spit-up and/or vomiting will be calculated for each group from data recorded on daily formula intake records during the study. |
| Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires | Change from Study Day 1 to Study Day 15 | Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15 |
| Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire. | Change from Study Day 1 to Study Day 15 | Parental responses to individual question on the Feeding and Stool Patterns Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15. |
Countries
United States
Outcome results
None listed