Impact of Infant Formula on Caregiver-perceived Intolerance

Healthy Infants Clinical Trial

Official title:

Impact of Infant Formula on Caregiver-perceived Intolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03679234
• Other study ID #: 18.01.US.INF
• Status: Completed
• Phase: N/A
• Start date: September 24, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: June 2020
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Understand the impact of switching to a commercially available infant formula on gastrointestinal symptoms

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: April 1, 2019
• Est. primary completion date: April 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 60 Days

Eligibility

Inclusion Criteria:

• Healthy infant

• Full-term (> 37 weeks gestation)

• Birth weight > 2500 and < 4500 g

• 14-60 days of age on enrollment

• Singleton birth

• Infant's mother has elected not to breastfeed prior to enrollment

• Infant exclusively formula-fed for at least 5 days prior to enrollment

• Caregiver perceives infant as very or extremely fussy according to perceived fussiness based on the previous 3 days

• Caregiver wishes to switch infant's formula

• Has not received solid foods

• Having obtained his/her legal representative's informed consent

Exclusion Criteria:

• Known or suspected cow-milk allergy

• Currently receiving a specialty infant formula (e.g. thickened, extensively hydrolyzed, amino acid-based, metabolic)

• Has switched formula more than two times since hospital discharge

• Currently experiencing gastrointestinal or respiratory symptoms secondary to an ongoing infection or virus (e.g. gastrointestinal infection, upper respiratory infection, flu)

• Congenital illness or malformation that may affect infant feeding and/or growth

• Any readmission to hospital (except for hyperbilirubinemia) prior to enrollment

• Receiving probiotic supplements

• Infant's family who in the Investigator's assessment cannot be expected to comply with treatment (feeding regimen).

• Participation in another study that has not been approved as a concomitant study by Nestlé Nutrition.

Related Conditions & MeSH terms

• Healthy Infants

Intervention

Other:
• Routine infant formula
Routine infant formula with probiotic

Locations

Country	Name	City	State
United States	Coastal Pediatric Associates	Charleston	South Carolina
United States	Ohio Pediatric Research Association	Dayton	Ohio
United States	Tanner Clinic	Layton	Utah
United States	Midsouth Center for Clinical Research, LLC	Memphis	Tennessee
United States	Norwich Pediatrics Group	Norwich	Connecticut
United States	Qualmedica Research	Owensboro	Kentucky
United States	ClinPoint Trials	Waxahachie	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant GI Symptom Burden	Study personnel will administer questionnaire	3 weeks
Secondary	Formula Intake	Caregivers will document on diary records	24 hours
Secondary	Fussiness	Caregivers will document on diary records	24 hours
Secondary	Formula Satisfaction Questionnaire	Study personnel will administer questionnaire	3 weeks
Secondary	Adverse Events	Assessed throughout study	24 hours and 3 weeks