Feeding Intolerance in Formula-Fed Infants

Feeding Intolerance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02028156
• Other study ID #: DA06
• Status: Terminated
• Phase: N/A
• First received: December 6, 2013
• Last updated: November 5, 2014
• Start date: January 2014
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Abbott Nutrition
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A to 60 Days

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Feeding Intolerance

Intervention

Other:
• Partially Hydrolyzed Infant Formula
Commercially available infant formula

Locations

Country	Name	City	State
China	Guangdong Women and Children Hospital	Guangzhou	Guangdong
China	Nanjing Maternity and Child Health Care Hospital	Nanjing	Jiangsu
China	Xin Hua Hospital	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Nutrition

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in Fussiness	Study phase 2; Parent completed questionnaire.	0 to 15 days	No
Secondary	Diarrhea	Study phase 1; Parent completed questionnaire.	0 to 4 weeks	No
Secondary	Constipation	Study phase 1; Parent completed questionnaire.	0 to 4 weeks	No
Secondary	Spit-up	Study phase 1; Parent completed questionnaire.	0 to 4 weeks	No
Secondary	Gassiness	Study phase 1; Parent completed questionnaire.	0 to 4 weeks	No