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OpenTrials
Completed

NCT Number: NCT01573871

Tolerance and Compliance of Infants Fed an Hydrolyzed Infant Formula

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

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Key information

Conditions

Infant Gastrointestinal Intolerance

Age range

Up to 180 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Northpoint Pediatrics, Indianapolis, Indiana, United States

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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 0 to 180 days of age
  • Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
  • Infant has not consumed an extensively hydrolyzed infant formula
  • Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
  • 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 through the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral during the study

Exclusion criteria

  • Participation in another study

Treatment and study plan

Experimental Hydrolyzed infant formula

Other

Experimental hydrolyzed infant formula to be fed ad libitum

Primary outcomes

  1. Weight maintenance

    Time frame: 14 days

Secondary outcomes

  1. Formula volume intake

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance and Compliance of Infants Fed an Extensively Hydrolyzed Infant Formula

Important dates

Study start
2012
Primary completion
2012
Study completion
2012
First posted
Apr 10, 2012
Registry last updated
Feb 15, 2013

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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