Feeding Intolerance in Formula-Fed Infants

Evaluation of Feeding Intolerance in Formula-Fed Infants: A Non-Randomized, Single-Group, Multi-Center Study

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

Study Overview

• Status: Terminated
• Conditions: Feeding Intolerance
• Intervention / Treatment: Other: Partially Hydrolyzed Infant Formula

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Xin Hua Hospital
  • Guangdong
    • Guangzhou, Guangdong, China
      • Guangdong Women and Children Hospital
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Nanjing Maternity and Child Health Care Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 month (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Partially Hydrolyzed Infant Formula; Fed ad lib.	Other: Partially Hydrolyzed Infant Formula; Commercially available infant formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in Fussiness	Study phase 2; Parent completed questionnaire.	0 to 15 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diarrhea	Study phase 1; Parent completed questionnaire.	0 to 4 weeks
Constipation	Study phase 1; Parent completed questionnaire.	0 to 4 weeks
Spit-up	Study phase 1; Parent completed questionnaire.	0 to 4 weeks
Gassiness	Study phase 1; Parent completed questionnaire.	0 to 4 weeks

Collaborators and Investigators

• Sponsor: Abbott Nutrition
• Investigators: Study Chair: Shirley Li, MD, Abbott Nutrition China

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: December 6, 2013
• First Submitted That Met QC Criteria: January 3, 2014
• First Posted (Estimate): January 7, 2014

Study Record Updates

• Last Update Posted (Estimate): November 7, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Other Study ID Numbers: DA06