Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Growth and Compliance of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03597113

Enrollment

320

Registered

2018-07-24

Start date

2018-01-31

Completion date

2020-03-27

Last updated

2021-03-03

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 purpose of this study is to evaluate the growth and compliance of an intended use population of infants receiving an extensively hydrolyzed infant formula.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

0 Days to 180 Days

Healthy volunteers

Inclusion criteria

* Infant is experiencing persistent feeding intolerance or allergy and diagnosed wtih Cow's Milk Protein Allergy (CMPA) or other condition where an extensively hydrolyzed formula is deemed appropriate by their healthcare professional * Infants using OTC medications, home remedies, herbal preparations or rehydration fluids that might affect GI tolerance * Parent(s) of infants enrolled on prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids directed by their healthcare professional, confirm their intention to continue their use during the study until directed by their healthcare professional to discontinue. * Infant is not receiving steroids. * Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study * Parent(s) confirm their intention not to administer solid foods or juices to their infant from enrollment through the duration of the study * Parent(s) confirm their intention not to administer vitamin or mineral supplements to their infant from enrollment through the duration of the study * Infant's parent(s) or a LAR has voluntarily signed and dated an informed consent form (ICF), approved by an Independent Ethics Committee/Institutional Review Board (IEC/IRB)

Exclusion criteria

* Participation in another study that has not been approved as a concomitant study by AN

Design outcomes

Primary

Measure	Time frame	Description
Weight	Baseline to Study Day 30	Measured in Kg

Secondary

Measure	Time frame	Description
Formula Intake	Baseline to Study Day 30	Parent completed diary

Countries

Turkey (Türkiye)

Outcome results