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OpenTrials
Completed

NCT Number: NCT02500563

Exploratory/Proof of Principle Microbiota Study

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

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Key information

Conditions

Fecal Microbiota

Age range

1 day–7 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Midwest Children's Health Research Institue

Lincoln, Nebraska, 68504, United States

About this study

This clinical trial will evaluate the stool of infants fed one of two infant formulas, which contain different types of proteins, or breast milk to determine if different proteins have an effect on the type of bacteria that enters and lives in an infant's intestine early in life.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Singleton, 1-7 days of age at registration or randomization
  • Term infant with appropriate birth weight for gestational age
  • Either solely formula fed or exclusively receiving mother's own breast milk
  • Signed Informed Consent and Protected Health Information

Exclusion criteria

  • Caesarean delivery
  • Infant was born from a mother with Type 1 diabetes
  • History of underlying metabolic or chronic disease or immunocompromised
  • Feeding difficulties or history of formula or human milk intolerance
  • Signs of acute infection of current use of antibiotics

Treatment and study plan

Amino acid based infant formula

Other

Extensively hydrolyzed casein infant formula

Other

Mother's own breast milk

Other

Primary outcomes

  1. Fecal microbiota measured at each visit

    Time frame: 8 weeks

    Sequencing and composition of samples

Secondary outcomes

  1. Body weight measured at each visit

    Time frame: 8 weeks

    Measurement collected with a calibrated infant scale

  2. Body length measured at each visit

    Time frame: 8 weeks

    Measurement collected with a standardized length board

  3. Head circumference measured at each visit

    Time frame: 8 weeks

    Measurement collected with a standardized measuring tape

  4. Parental recall of formula intake at each visit

    Time frame: 8 weeks

  5. Stool collection at each visit

    Time frame: 8 weeks

    Composite measure of pH and short chain fatty acids

  6. Serious adverse events collected throughout the study period

    Time frame: 8 weeks

Sponsors and collaborators

Lead sponsor

Mead Johnson Nutrition

Industry

Collaborators

  • Midwest Children's Health Research Institute

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
Jul 28, 2017

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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