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Tolerance of Healthy Term Infants Fed Infant Formulas #3

Tolerance of Healthy Term Infants Fed Infant Formulas

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00977964
Enrollment
270
Registered
2009-09-16
Start date
2009-09-30
Completion date
2010-01-31
Last updated
2010-11-25

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

Conditions

Gastrointestinal Tolerance

Keywords

Infant

Brief summary

The primary objective of this study is to assess the comparative gastrointestinal (GI) tolerance of normal term infants to six experimental milk protein-based powdered infant formulas.

Interventions

OTHERExperimental milk protein infant formula Process E

ad lib from 1-8 days of age until 28 days of age

OTHERExperimental milk protein infant formula Process F

ad lib from 1-8 days of age until 28 days of age

OTHERExperimental milk protein infant formula Process A

ad lib for 1-8 days of age until 28 days of age

OTHERExperimental milk protein infant formula Process B

ad lib from 1-8 days of age until 28 days of age

OTHERExperimental milk protein infant formula Process C

ad lib from 1-8 days of age to 28 days of age

OTHERExperimental milk protein infant formula Process D

ad lib from 1-8 days of age until 28 days of age

Sponsors

Abbott Nutrition
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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. * Infant's birth weight was \> 2490 g (\ 5 lbs 8 oz. * Infant is between 0 and 8 days of age at enrollment. * Infants using medications, home remedies ,herbal preparations or rehydration fluids that might affect GI tolerance may not be enrolled. * 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, unless instructed otherwise by their healthcare professional.

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 has been treated with antibiotics. * Infant has received probiotics.

Design outcomes

Primary

MeasureTime frame
The primary variable is Gastrointestinal tolerance.1-28 days of age

Secondary

MeasureTime frame
The secondary variables are additional measures of GI tolerance and parental feedback.1-28 days of age

Countries

United States

Outcome results

None listed

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