Study in Unsettled Infants Experiencing Feeding Intolerance

Feeding Disorder Clinical Trial

Official title:

Effect of an Experimental Infant Formula in Unsettled Infants Experiencing Feeding Intolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02021058
• Other study ID #: 13.10.INF
• Status: Completed
• Phase: N/A
• Start date: December 12, 2013
• Est. completion date: August 23, 2016

Study information

• Verified date: September 2021
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Multinational, multicenter, clinical trial. To evaluate the effect of an experimental formula on GI symptoms and associated behaviors in unsettled infants with parent-reported feeding intolerance

Description:

The purpose of the present study is therefore to evaluate the effect of an experimental formula in an unsettled formula-fed infant population whose parents are considering switching formulas due to perceived feeding intolerance.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 259
• Est. completion date: August 23, 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 90 Days

Eligibility

Inclusion Criteria:

1. Full term infants, singleton, healthy at birth

2. Infants of parent(s)/LAR who have previously made the decision to exclusively formula feed their infant.

3. Infants exclusively consuming a standard formula for a minimum of 3 consecutive days prior to enrolment.

4. Infant's parent(s)/LAR are of legal age of consent and are willing and able to fulfil the requirements of the study protocol.

Exclusion Criteria:

1. Infants who are consuming any amount of supplemental human milk

2. Infants who are consuming weaning foods or beverages other than infant formula

3. Infants with known cow's milk allergy or family history of siblings with documented cow's milk protein intolerance/allergy

4. Infants who have a medical condition or history that could cause or contribute to feeding intolerance

5. Infants who received any other investigational intervention or who have participated in another clinical trial prior to enrolment

Related Conditions & MeSH terms

• Feeding and Eating Disorders
• Feeding Disorder

Intervention

Other:
• Experimental Formula
Experimental formula
• Standard control formula
Standard Infant formula

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin, New Territories
Philippines	Asian Hospital and Medical Center	Muntinlupa
Taiwan	Chang Gung Memorial Hospital - Linkou	Hsiang, Taoyan Hsien
Taiwan	Mackay Memorial Hospital - Tamsui	New Taipei City
Taiwan	Mackay Memorial Hospital - Taipei	Taipei City
Thailand	King Chulalongkorn Memorial Hospital - Faculty of Medicine, Chulalongkorn University	Pratumwan, Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Countries where clinical trial is conducted

Hong Kong,  Philippines,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes from baseline to 14 days in fuss-cry behavior	fuss-cry behavior per 24 hours	from baseline to 14 days
Secondary	Change from baseline to 14 days in GI symptoms		from baseline to 14 days