NCT01573871

Brief Summary

The objective of the study is to assess gastrointestinal tolerance and compliance in infants who require a hydrolyzed formula.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

3 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

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 6, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

7 months

First QC Date

April 6, 2012

Last Update Submit

February 14, 2013

Conditions

InfantGastrointestinal Intolerance

Outcome Measures

Primary Outcomes (1)

  • Weight maintenance

    14 days

Secondary Outcomes (1)

  • Formula volume intake

    14 days

Study Arms (1)

Hydrolyzed infant formula

EXPERIMENTAL

Hydrolyzed infant formula to be fed ad libitum

Other: Experimental Hydrolyzed infant formula

Interventions

Experimental Hydrolyzed infant formulaOTHER

Experimental hydrolyzed infant formula to be fed ad libitum

Hydrolyzed infant formula

Eligibility Criteria

AgeUp to 180 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infant is 0 to 180 days of age
  • Infant with persistent feeding intolerance symptoms; has had at least 1 formula switch OR infant is experiencing/being managed with an extensively hydrolyzed formula for suspected food protein intolerance or allergy or other condition where an extensively hydrolyzed formula is deemed appropriate
  • Infant has not consumed an extensively hydrolyzed infant formula
  • Use of prescription medications, OTC medications, home remedies, herbal preparations or rehydration fluids restricted
  • Infant is not receiving steroids.
  • Parent(s) confirm their intention to feed their infant the study product as the sole source of nutrition for the duration of the study
  • Parent(s) confirm their intention not to administer solid foods or juices to their infant through the duration of the study.
  • Parent(s) confirm their intention not to administer vitamin or mineral during the study

You may not qualify if:

  • Participation in another study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Northpoint Pediatrics

Indianapolis, Indiana, 46038, United States

Location

Metro-Health Medical Center

Cleveland, Ohio, 44109, United States

Location

Ohio Pediatric Research Association

Huber Heights, Ohio, 45424, United States

Location

Study Officials

  • Marlene Borschel, PhD

    Abbott Nutrition

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2012

First Posted

April 10, 2012

Study Start

February 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

US(3)