Study Stopped
Low enrollment
Feeding Intolerance in Formula-Fed Infants
Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study
1 other identifier
interventional
3
1 country
3
Brief Summary
This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2014
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 6, 2013
CompletedStudy Start
First participant enrolled
January 1, 2014
CompletedFirst Posted
Study publicly available on registry
January 7, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedNovember 7, 2014
November 1, 2014
7 months
December 6, 2013
November 5, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Improvement in Fussiness
Study phase 2; Parent completed questionnaire.
0 to 15 days
Secondary Outcomes (4)
Diarrhea
0 to 4 weeks
Constipation
0 to 4 weeks
Spit-up
0 to 4 weeks
Gassiness
0 to 4 weeks
Study Arms (1)
Partially Hydrolyzed Infant Formula
EXPERIMENTALFed ad lib.
Interventions
Commercially available infant formula
Eligibility Criteria
You may qualify if:
- Singleton full term birth with birth weight of \> 2500g.
- Infant between 0 and 60 days of age.
- Discontinuation of medications that might affect gastrointestinal (GI) tolerance.
- Infant is exclusively formula-fed a full-lactose, intact cow milk protein-based infant formula (CMF) for less than 7 days prior to enrollment.
- Infant was fed according to protocol in Stage 1 of the study.
- Infant was identified as being fussy using the Intolerance Assessment Tool in Stage 1.
You may not qualify if:
- Chromosomal or major congenital anomalies.
- Suspected or known metabolic or physical diseases affecting infant feeding and/or metabolism.
- Hospitalization, other than for delivery, prior to enrollment.
- Severe uncontrolled eczema, visible bloody stools or milk protein allergy prior to enrollment.
- More than 1 substitution of an infant formula other than full-lactose, intact cow milk formula (CMF) since birth.
- Use of a prokinetic drug within 7 days before enrollment.
- Infant's intolerance symptom was caused by another reason, for example known infection/illness, food allergy, or response to vaccination(s).
- Infant has immunization(s) within 3 days of enrollment in Stage 2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Abbott Nutritionlead
Study Sites (3)
Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Xin Hua Hospital
Shanghai, China
Study Officials
- STUDY CHAIR
Shirley Li, MD
Abbott Nutrition China
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2013
First Posted
January 7, 2014
Study Start
January 1, 2014
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
November 7, 2014
Record last verified: 2014-11