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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02028156
Other study ID # DA06
Secondary ID
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


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
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