Exploratory/Proof of Principle Microbiota Study

July 27, 2017 updated by: Mead Johnson Nutrition
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68504
        • Midwest Children's Health Research Institue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 week (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Amino acid based infant formula
Other: Amino acid based infant formula
Experimental: Extensively hydrolyzed casein infant formula
Other: Extensively hydrolyzed casein infant formula
Other: Mother's own breast milk
Other: Mother's own breast milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fecal microbiota measured at each visit
Time Frame: 8 weeks
Sequencing and composition of samples
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight measured at each visit
Time Frame: 8 weeks
Measurement collected with a calibrated infant scale
8 weeks
Body length measured at each visit
Time Frame: 8 weeks
Measurement collected with a standardized length board
8 weeks
Head circumference measured at each visit
Time Frame: 8 weeks
Measurement collected with a standardized measuring tape
8 weeks
Parental recall of formula intake at each visit
Time Frame: 8 weeks
8 weeks
Stool collection at each visit
Time Frame: 8 weeks
Composite measure of pH and short chain fatty acids
8 weeks
Serious adverse events collected throughout the study period
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mead Johnson Nutrition

Collaborators

Midwest Children's Health Research Institute

Investigators

  • Study Director: Jon Vanderhoof, M.D., Mead Johnson and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

July 15, 2015

First Submitted That Met QC Criteria

July 15, 2015

First Posted (Estimate)

July 16, 2015

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 27, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6032 (CTEP)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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