NCT02322138

Brief Summary

The study objective is to evaluate the gastrointestinal tolerance of infant formula supplemented with prebiotics.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 23, 2014

Completed
9 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

5 months

First QC Date

December 17, 2014

Last Update Submit

July 22, 2015

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

  • Stool Consistency Questionnaire

    Questionnaire

    Baseline to 35 Days of Age

Secondary Outcomes (5)

  • Stools per Day Questionnaire

    Baseline to 35 Days of Age

  • Feeding Spit Up Questionnaire

    Baseline to 35 Days of Age

  • Weight

    Baseline to 35 Days of Age

  • Length

    Baseline to 35 Days of Age

  • Head Circumference

    Baseline to 35 Days of Age

Study Arms (3)

Experimental 1 Infant Formula

EXPERIMENTAL

Milk-based infant formula without prebiotics

Other: Experimental 1 Infant Formula

Experimental 2 Infant Formula

EXPERIMENTAL

Milk-based infant formula with prebiotics

Other: Experimental 2 Infant Formula

Human Milk-Fed Reference Group

OTHER

Breast fed infants

Other: Reference Group

Interventions

Experimental 1 Infant FormulaOTHER

Ready to feed infant formula to be fed ad-libitum

Experimental 1 Infant Formula
Experimental 2 Infant FormulaOTHER

Ready to feed infant formula to be fed ad-libitum

Experimental 2 Infant Formula
Reference GroupOTHER

Breast fed ad libitum

Human Milk-Fed Reference Group

Eligibility Criteria

AgeUp to 8 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Infant is judged to be in good health.
  • Infant is a singleton from a full term birth with a gestational age of 37-42 weeks.
  • Infant's birth weight was \> 2490 g (\~5 lbs 8 oz.).
  • Infant is between 0 and 8 days of age at enrollment.
  • Parent(s) confirm their intention to feed their infant the study product (formula-fed infants) or human milk (human milk-fed infants) as the sole source of nutrition for the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral supplements, solid foods or juices to their infant from enrollment through the duration of the study.

You may not qualify if:

  • Adverse maternal, fetal or infant medical history that effects tolerance, growth, and/or development.
  • Infants using medications, home remedies, herbal preparations, probiotics or rehydration fluids that might affect GI tolerance.
  • Mother intends to use a combination of breast and formula feeding.
  • Participation in another study that has not been approved as a concomitant study by AN.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

W.O.M.B Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

Clinical Research Advantage/Colorado Springs Health Partners

Colorado Springs, Colorado, 80920, United States

Location

Norwich Pediatric Group, PC

Norwich, Connecticut, 06360, United States

Location

SCORE Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

Michael W. Simon, M.D., PSC

Nicholasville, Kentucky, 40356, United States

Location

Women's Clinic of Lincoln, PC.

Lincoln, Nebraska, 68510, United States

Location

White Oak Family Physicians DBA Asheboro Research Associates

Asheboro, North Carolina, 27203, United States

Location

Institute of Clinical Research

Mayfield Heights, Ohio, 44124, United States

Location

The Cleveland Pediatric Research Center, LLC

Middleburg Heights, Ohio, 44130, United States

Location

Tanner Memorial Clinic

Layton, Utah, 84041, United States

Location

Study Officials

  • Janice Kajzer, MS, RD, LD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2014

First Posted

December 23, 2014

Study Start

January 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

US(10)