Tolerance of Healthy Infants Fed Infant Formulas

Gastrointestinal Tolerance Clinical Trial

Official title:

Tolerance of Healthy Infants Fed Infant Formulas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02401217
• Other study ID #: AL12
• Status: Completed
• Phase: N/A
• First received: March 16, 2015
• Last updated: January 11, 2016
• Start date: April 2015
• Est. completion date: September 2015

Study information

• Verified date: January 2016
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 126
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 30 Days

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)

Related Conditions & MeSH terms

• Gastrointestinal Tolerance

Intervention

Other:
• Phase 1- Arm 1 Infant Formula
Powder infant formula
• Phase 2- Arm 2 Infant Formula
Powder infant formula
• Phase 2- Arm 3 Infant Formula
Powder infant formula

Locations

Country	Name	City	State
United States	White Oak Family Physicians DBA/Asheboro Research Associates	Asheboro	North Carolina
United States	Tanner Memorial Clinic	Layton	Utah
United States	Institute of Clinical Research, LLC	Mayfield Heights	Ohio
United States	The Cleveland Pediatric Research Center, LLC	Middleburg Heights	Ohio
United States	SCORE Physician Alliance LLC	St. Petersburg	Florida
United States	W.O.M.B Watching Over Mothers and Babies	Tucson	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries	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.	Change from Study Day 1 to Study Day 15	No
Secondary	Mean Percentage of stools representing each stool consistency and color using parent reported diaries	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.	Change from Study Day 1 to Study Day 15	No
Secondary	Mean predominant stool consistency and color measured using parent reported diaries	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.	Change from Study Day 1 to Study Day 15	No
Secondary	Average number of stools per day measured using parent reported diaries	Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study.	Change from Study Day 1 to Study Day 15	No
Secondary	Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.	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.	Change from Study Day 1 to Study Day 15	No
Secondary	Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires	Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15	Change from Study Day 1 to Study Day 15	No
Secondary	Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.	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.	Change from Study Day 1 to Study Day 15	No