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Completed

NCT Number: NCT03628183

Tolerance of Infants Fed a Hydrolysate Formula

This is a prospective, randomized, multicenter study to assess the tolerance of infant formulas.

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Key information

Conditions

Gastrointestinal Tolerance

Age range

Up to 14 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Watching Over Mothers and Babies, Tucson, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subject is judged to be in good health
  • Singleton from a full-term birth
  • Birth weight was > or = to 2490 g
  • Between 0 and 14 days of age at enrollment
  • Parent(s) confirm their intention to feed their infant the assigned study product 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
  • Subject's parent(s) has voluntarily signed and dated an Informed Consent Form (ICF)

Exclusion criteria

  • An adverse maternal, fetal or subject medical history that is thought by the investigator to have potential for effects on tolerance, growth, and/or development.
  • Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
  • Subject participates in another study that has not been approved as a concomitant study
  • Subject has an allergy or intolerance to any ingredient in the study product
  • Subject has been treated with antibiotics within 2 weeks prior to enrollment

Treatment and study plan

Hydrolysate Infant Formula 1

Other

Feed ad lib

Hydrolysate Infant Formula 2

Other

Feed ad lib

Primary outcomes

  1. Stool Characteristics

    Time frame: Study Day 1 - Study Day 21

    Parent completed diary

Secondary outcomes

  1. Formula Intake

    Time frame: Study Day 1 - Study Day 21

    Parent completed diary

  2. Weight

    Time frame: Study Day 1 - Study Day 21

    Scale

  3. Length

    Time frame: Study Day 1 - Study Day 21

    Length board

Sponsors and collaborators

Lead sponsor

Abbott Nutrition

Industry

Registry information

Official study title

Tolerance of Infants Fed a Hydrolysate Formula Manufactured With a New Processing Method

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 14, 2018
Registry last updated
Dec 19, 2018

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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