NCT02746016

Brief Summary

This is a prospective, multi-center, single-arm study to evaluate the symptoms of formula intolerance in healthy term infants.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

13 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

Study Start

First participant enrolled

April 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 21, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

6 months

First QC Date

April 13, 2016

Last Update Submit

March 28, 2017

Conditions

Gastrointestinal Tolerance

Outcome Measures

Primary Outcomes (1)

  • Fussiness

    Parent Questionnaires

    Change from baseline (3 days prior to SD1) to within one day of initiation of study feeding (SD1)

Secondary Outcomes (4)

  • Fussiness

    Baseline to SDAY 29

  • Hours of daily crying

    Baseline to SDAY 29

  • Gastrointestinal Tolerance

    Baseline to SDAY 29

  • Stool Pattern

    Baseline to SDAY 29

Study Arms (1)

Infant Formula supplemented with Oligosaccharides

EXPERIMENTAL

Ready to feed infant formula ; Feed ad libitum.

Other: Infant Formula supplemented with Oligosaccharides

Interventions

Infant Formula supplemented with OligosaccharidesOTHER

sole source nutrition

Infant Formula supplemented with Oligosaccharides

Eligibility Criteria

Age7 Days - 42 Days
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Subject is in good health as determined from subject's medical history by parent report
  • Subject is a singleton full-term birth with a gestational age of 37 - 42 weeks
  • Subject's birth weight was ≥ 2490 g (\~5 lbs. 8 oz.)
  • Subject is between 7 and 42 days of age
  • Infant was identified by parents as very fussy or extremely fussy in the baseline tolerance evaluation
  • Infant is exclusively formula-fed at time of study entry
  • 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
  • Subject's parent(s) has voluntarily signed and dated an informed consent form (ICF) prior to any participation in the study

You may not qualify if:

  • An adverse maternal, fetal or subject medical history that has potential for effects on tolerance, growth, and/or development
  • Subject is taking and plans to continue medications, home remedies, herbal preparations or rehydration fluids that might affect gastrointestinal (GI) tolerance
  • Subject participates in another study that has not been approved as a concomitant study
  • Subject has been fed any formula containing human milk oligosaccharides prior to study enrollment
  • Subject has been treated with oral antibiotics within 7 days prior to study enrollment
  • Mother intends to use a combination of breast and formula feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (13)

Alabama Clinical Therapeutics, LLC

Birmingham, Alabama, 35235, United States

Location

Southeastern Pediatric Associates

Dothan, Alabama, 36305, United States

Location

Watching Over Mothers and Babies

Tucson, Arizona, 85712, United States

Location

Norwich Pediatric Group, PC

Norwich, Connecticut, 06360, United States

Location

Florida Institute for Clinical Research, LLC

Orlando, Florida, 32825, United States

Location

Score Physician Alliance, LLC

St. Petersburg, Florida, 33710, United States

Location

Women's Clinic of Lincoln, PC

Lincoln, Nebraska, 68510, United States

Location

Institute of Clinical Research, LLC

Cleveland, Ohio, 44124, United States

Location

Aventiv Research

Grove City, Ohio, 43123, United States

Location

Coastal Pediatric Research

Charleston, South Carolina, 29414, United States

Location

DCOL Center for Clinical Research

Longview, Texas, 75605, United States

Location

Southwest Children's Research Associates, P.A.

San Antonio, Texas, 78229, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

MeSH Terms

Interventions

Oligosaccharides

Intervention Hierarchy (Ancestors)

PolysaccharidesCarbohydrates

Study Officials

  • Marlene Borschel, PhD, RD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2016

First Posted

April 21, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2016

Study Completion

October 1, 2016

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

US(13)