Exploratory/Proof of Principle Microbiota Study

Fecal Microbiota Clinical Trial

Official title:

Exploratory/Proof of Principle Microbiota Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02500563
• Other study ID #: 6032
• Status: Completed
• Phase: N/A
• First received: July 15, 2015
• Last updated: July 27, 2017
• Start date: July 2015
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Mead Johnson Nutrition
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Fecal Microbiota

Intervention

Other:
• Amino acid based infant formula

• Extensively hydrolyzed casein infant formula

• Mother's own breast milk

Locations

Country	Name	City	State
United States	Midwest Children's Health Research Institue	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Mead Johnson Nutrition	Midwest Children's Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fecal microbiota measured at each visit	Sequencing and composition of samples	8 weeks
Secondary	Body weight measured at each visit	Measurement collected with a calibrated infant scale	8 weeks
Secondary	Body length measured at each visit	Measurement collected with a standardized length board	8 weeks
Secondary	Head circumference measured at each visit	Measurement collected with a standardized measuring tape	8 weeks
Secondary	Parental recall of formula intake at each visit		8 weeks
Secondary	Stool collection at each visit	Composite measure of pH and short chain fatty acids	8 weeks
Secondary	Serious adverse events collected throughout the study period		8 weeks