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Completed

NCT Number: NCT03597113

Evaluation of Infants Fed an Extensively Hydrolyzed Hypo Allergenic Infant Formula

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.

Completed

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Key information

Conditions

Gastrointestinal Tolerance

Age range

0 day–180 day

Sex eligibility

All sexes

Study type

Observational

Primary location

Adana City Hospital, Adana, Turkey (Türkiye)

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Weight

    Time frame: Baseline to Study Day 30

    Measured in Kg

Secondary outcomes

  1. Formula Intake

    Time frame: Baseline to Study Day 30

    Parent completed diary

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Jul 24, 2018
Registry last updated
Mar 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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