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Layton, Utah 84041

  • Gastrointestinal Tolerance

Purpose:

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.


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.


Study is Available At:


Original ID:

AL12


NCT ID:

NCT02401217


Secondary ID:


Study Acronym:


Brief Title:

Tolerance of Healthy Infants Fed Infant Formulas


Official Title:

Tolerance of Healthy Infants Fed Infant Formulas


Overall Status:

Completed


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

30 Days


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Abbott Nutrition


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Intervention Model: Parall


Number of Arms:

3


Number of Groups:

0


Total Enrollment:

126


Enrollment Type:

Actual


Overall Contact Information

Official Name:Marlene Borschel, PhD, RD
Study Chair
Abbott Nutrition

Study Dates

Start Date:April 2015
Completion Date:September 2015
Completion Type:Actual
Primary Completion Date:September 2015
Primary Completion Type:Actual
Verification Date:January 2016
Last Changed Date:January 11, 2016
First Received Date:March 16, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Stool consistency measured by Mean Rank Stool Consistency (MRSC) using parent reported diaries
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Mean Percentage of stools representing each stool consistency and color using parent reported diaries
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description: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
Outcome Type:Secondary Outcome
Measure:Mean predominant stool consistency and color measured using parent reported diaries
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Average number of stools per day measured using parent reported diaries
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description:Average number of stools/day will be calculated for each group from data recorded on daily stool records during the study.
Outcome Type:Secondary Outcome
Measure:Mean percentages of feedings associated with spit-up and/or vomit measured using parent reported diaries.
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description: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.
Outcome Type:Secondary Outcome
Measure:Parental responses to Formula Satisfaction and Infant Feeding and Stool Patterns Questionnaires
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description:Parental responses to individual question on the Formula Satisfaction Questionnaire will be calculated from data recorded on the questionnaire at Study Day 15
Outcome Type:Secondary Outcome
Measure:Parental assessment of infant feeding and stool patterns measured by the Infant Feeding and Stool Patterns Questionnaire.
Time Frame:Change from Study Day 1 to Study Day 15
Safety Issues:False
Description: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.

Study Interventions

Intervention Type:Other
Name:Phase 1- Arm 1 Infant Formula
Description:Powder infant formula
Arm Name:Phase 1-Arm 1 Infant Formula
Intervention Type:Other
Name:Phase 2- Arm 2 Infant Formula
Description:Powder infant formula
Arm Name:Phase 2- Arm 2 Infant Formula
Intervention Type:Other
Name:Phase 2- Arm 3 Infant Formula
Description:Powder infant formula
Arm Name:Phase 2- Arm 3 Infant Formula

Study Arms

Study Arm Type:Experimental
Arm Name:Phase 1-Arm 1 Infant Formula
Description:Milk-based infant formula manufactured by an alternative method. Non-commercially available formula. To be fed ad libitum.
Study Arm Type:Active Comparator
Arm Name:Phase 2- Arm 2 Infant Formula
Description:Milk-based infant formula using current manufacturing and ingredients. Non-commercially available formula. To be fed ad libitum.
Study Arm Type:Experimental
Arm Name:Phase 2- Arm 3 Infant Formula
Description:Milk-based infant formula using a new protein. Non-commercially available formula. To be fed ad libitum.

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Abbott Nutrition

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: April 03, 2020

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