Gastrointestinal Tolerance of Infant Formula

Gastrointestinal Tolerance of Formula Supplemented With Prebiotics

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02322138

Enrollment

131

Registered

2014-12-23

Start date

2015-01-31

Completion date

2015-06-30

Last updated

2015-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastrointestinal Tolerance

Brief summary

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Interventions

OTHERExperimental 1 Infant Formula

Ready to feed infant formula to be fed ad-libitum

OTHERExperimental 2 Infant Formula

Ready to feed infant formula to be fed ad-libitum

OTHERReference Group

Breast fed ad libitum

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

No minimum to 8 Days

Healthy volunteers

Yes

Inclusion criteria

* Infant is judged to be in good health. * Infant is a singleton from a full term birth with a gestational age of 37-42 weeks. * Infant's birth weight was \> 2490 g (\ 5 lbs 8 oz.). * Infant is between 0 and 8 days of age at enrollment. * Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study. * 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

* Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development. * Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance. * Mother intends to use a combination of breast and formula feeding. * Participation in another study that has not been approved as a concomitant study by AN.

Design outcomes

Primary

Measure	Time frame	Description
Stool Consistency Questionnaire	Baseline to 35 Days of Age	Questionnaire

Secondary

Measure	Time frame	Description
Stools per Day Questionnaire	Baseline to 35 Days of Age	Questionnaire
Feeding Spit Up Questionnaire	Baseline to 35 Days of Age	Questionnaire
Weight	Baseline to 35 Days of Age	Measured
Length	Baseline to 35 Days of Age	Measured
Head Circumference	Baseline to 35 Days of Age	Measured

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026