Feeding Intolerance in Formula-Fed Infants

Not Applicable

Terminated

• Conditions: Feeding Intolerance
• Interventions: Other: Partially Hydrolyzed Infant Formula

• Registration Number: NCT02028156
• Lead Sponsor: Abbott Nutrition

Brief Summary

This is a non-randomized, single-group, multi-center, two phased study to evaluate formula intolerance.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-12-06
• Study Start: 2014-01
• Study First Submitted QC: 2014-01-03
• Study First Posted: 2014-01-07
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-05
• Last Update Posted: 2014-11-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

Inclusion Criteria

Inclusion Criteria for Stage 1:

• 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.

Inclusion Criteria for Stage 2:

• 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

Exclusion Criteria for Stage 1:

• 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.

Exclusion Criteria for Stage 2:

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Partially Hydrolyzed Infant Formula	Partially Hydrolyzed Infant Formula	Fed ad lib.

Primary Outcome Measures

Name	Time	Method
Improvement in Fussiness	0 to 15 days	Study phase 2; Parent completed questionnaire.

Secondary Outcome Measures

Name	Time	Method
Constipation	0 to 4 weeks	Study phase 1; Parent completed questionnaire.
Gassiness	0 to 4 weeks	Study phase 1; Parent completed questionnaire.
Diarrhea	0 to 4 weeks	Study phase 1; Parent completed questionnaire.
Spit-up	0 to 4 weeks	Study phase 1; Parent completed questionnaire.

Trial Locations

Locations (3)

Xin Hua Hospital; 🇨🇳 Shanghai, China

Guangdong Women and Children Hospital; 🇨🇳 Guangzhou, Guangdong, China

Nanjing Maternity and Child Health Care Hospital; 🇨🇳 Nanjing, Jiangsu, China