Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
3 participants
INTERVENTIONAL
2014-01-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Partially Hydrolyzed Infant Formula
Fed ad lib.
Partially Hydrolyzed Infant Formula
Commercially available infant formula
Interventions
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Partially Hydrolyzed Infant Formula
Commercially available infant formula
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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.
60 Days
ALL
Yes
Sponsors
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Abbott Nutrition
INDUSTRY
Responsible Party
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Principal Investigators
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Shirley Li, MD
Role: STUDY_CHAIR
Abbott Nutrition China
Locations
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Guangdong Women and Children Hospital
Guangzhou, Guangdong, China
Nanjing Maternity and Child Health Care Hospital
Nanjing, Jiangsu, China
Xin Hua Hospital
Shanghai, , China
Countries
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Other Identifiers
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DA06
Identifier Type: -
Identifier Source: org_study_id