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OpenTrials
Completed

NCT Number: NCT03223792

Acceptance Of A Partially-Hydrolyzed Infant Formula

This clinical trial will evaluate stool consistency in infants receiving one of two study formulas through a 14-day feeding period.

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Key information

Conditions

Stool

Age range

28 day–300 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Birmingham Pediatric Associates, Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton 28-300 days of age at randomization
  • Gestational age less than or equal to 35 weeks
  • Receiving minimum 18oz infant formula in the 24hrs prior to randomization
  • History of hard stools or stooling difficulty
  • Signed informed consent and protected health information

Exclusion criteria

  • Current diagnosis of cow's milk protein allergy or intolerance
  • Use of extensively hydrolyzed or amino acid formula at randomization
  • Any abdominal or gastrointestinal surgery prior to randomization
  • History of underlying metabolic or chronic disease or congenital malformation
  • Organic causes of constipation

Treatment and study plan

Control

Other

Routine cow's milk-based infant formula

Investigational

Other

Partially-hydrolyzed cow's milk protein infant formula

Primary outcomes

  1. Stool consistency measured by MJN stool consistency scale

    Time frame: 14 days

Secondary outcomes

  1. Stool frequency

    Time frame: 14 days

  2. Formula acceptance measured by intake diary

    Time frame: 14 days

  3. Formula gastrointestinal tolerance measured by diary

    Time frame: 14 days

  4. Bowel movement characteristics by diary

    Time frame: 14 days

  5. Medically confirmed adverse events throughout the study period

    Time frame: 14 days

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 21, 2017
Registry last updated
Jan 9, 2019

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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