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OpenTrials
Completed

NCT Number: NCT02340143

Assessing Early Behavioral Indicators of Formula Tolerance

The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.

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Key information

Conditions

Tolerance

Age range

14 day–28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Nutrition Research Center

Houston, Texas, 77030, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton at birth
  • Term infant with birth weight of 2500 g or more
  • Crying or fussing for 3 or more hours per day
  • Consuming mostly infant formula
  • Signed Informed Consent and Protected Health Information authorization

Exclusion criteria

  • Current use of extensively hydrolyzed or amino acid infant formula
  • Planned use of probiotics during the study
  • History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
  • Enrollment in another interventional clinical research study

Treatment and study plan

Control

Other

Marketed partially hydrolyzed cow's milk protein infant formula

Investigational

Other

Partially hydrolyzed cow's milk protein infant formula with a probiotic

Primary outcomes

  1. Infant Behavior Diary

    Time frame: 21 Days

Secondary outcomes

  1. Recall of Tolerance Questionnaire

    Time frame: Baseline and Day 21

  2. Body Weight

    Time frame: Baseline and Day 21

  3. Infant Behavior Questionnaire - Revised

    Time frame: Baseline and Day 21

  4. Recall of formula intake at each visit

    Time frame: Baseline, Day 10, and Day 18

  5. Fecal microbiome and Fecal calprotectin

    Time frame: Baseline and Day 21

  6. Medically-confirmed Adverse Events

    Time frame: 21 Days

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Baylor College of Medicine

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jan 16, 2015
Registry last updated
Sep 14, 2016

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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