NCT01813526

Brief Summary

Infants with protein sensitive colitis fed a nutritionally complete free amino acid-based medical food will be evaluated for 42 days.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 1999

Geographic Reach
1 country

2 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

November 1, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 19, 2013

Completed
Last Updated

March 19, 2013

Status Verified

March 1, 2013

Enrollment Period

1.3 years

First QC Date

March 14, 2013

Last Update Submit

March 15, 2013

Conditions

Protein Sensitive Colitis

Outcome Measures

Primary Outcomes (1)

  • Physician Rated Symptom Score

    Calculated from a symptom checklist based on parent report of the previous 7 day history; Change in physician rated symptom score from SD 1 to SD 43.

    Study Day (SD) 1 and 43

Secondary Outcomes (5)

  • Mean Rank Stool Consistency

    Study Day (SD) 2-4 and 40-42

  • Weight

    Study Day (SD) 1 and 43 Visits

  • Formula Intake

    Study Day (SD) 2-4 and 40-42

  • Daily Stool Number

    Study Day (SD) 2-4 and 40-42

  • Stool Occult Blood

    Study Day (SD) 2-4 and 40-42

Study Arms (1)

Experimental Infant Formula

EXPERIMENTAL

Experimental formula to be fed ad libitum.

Other: Experimental Infant Formula

Interventions

Experimental Infant FormulaOTHER

Nutritionally complete free amino acid-based medical food.

Also known as: EleCare
Experimental Infant Formula

Eligibility Criteria

AgeUp to 6 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Less than or equal to 6 months of age
  • weeks gestational age at birth
  • Singleton or Twin birth
  • Diagnosed with protein sensitive colitis
  • Negative stool culture at time of study entry
  • No previous history of consuming free amino acid-based medical food
  • Not receiving cisapride or steroids
  • No vitamin mineral supplement administration during the study period with the exception of iron or fluoride
  • No milk or soy products for the duration of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Children's Hospital

Omaha, Nebraska, 68114, United States

Location

Related Publications (1)

  • Amari S, Shahrook S, Namba F, Ota E, Mori R. Branched-chain amino acid supplementation for improving growth and development in term and preterm neonates. Cochrane Database Syst Rev. 2020 Oct 2;10(10):CD012273. doi: 10.1002/14651858.CD012273.pub2.

    PMID: 33006765DERIVED

Study Officials

  • Marlene Borschel, PhD, RD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2013

First Posted

March 19, 2013

Study Start

November 1, 1999

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

March 19, 2013

Record last verified: 2013-03

Locations

US(2)