Impact of Infant Formula on Caregiver-perceived Intolerance

NCT03679234 | Completed

• 1 other identifier: 18.01.US.INF
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 7

Brief Summary

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

Conditions

Healthy Infants

Outcome Measures

Primary Outcomes (1)

• Infant GI Symptom Burden

  Study personnel will administer questionnaire

  3 weeks

Secondary Outcomes (4)

• Formula Intake

  24 hours

• Fussiness

  24 hours

• Formula Satisfaction Questionnaire

  3 weeks

• Adverse Events

  24 hours and 3 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Routine infant formula

Other: Routine infant formula

Interventions

Routine infant formula OTHER

Routine infant formula with probiotic

Intervention

Eligibility Criteria

• Age: 14 Days - 60 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infant
• Full-term (\> 37 weeks gestation)
• Birth weight \> 2500 and \< 4500 g
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (7)

Norwich Pediatrics Group

Norwich, Connecticut, 06360, United States

Location

Qualmedica Research

Owensboro, Kentucky, 42301, United States

Location

Ohio Pediatric Research Association

Dayton, Ohio, 45414, United States

Location

Coastal Pediatric Associates

Charleston, South Carolina, 29414, United States

Location

Midsouth Center for Clinical Research, LLC

Memphis, Tennessee, 38116, United States

Location

ClinPoint Trials

Waxahachie, Texas, 75165, United States

Location

Tanner Clinic

Layton, Utah, 84041, United States

Location

Study Officials

• Ryan Carvalho, MD

  Nestle Nutrition

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Subjects and their parent/caregiver will be blinded to the intervention product. Care Providers at sites, Investigators, and Outcomes Assessors are unblinded to the intervention product.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2018
• First Posted: September 20, 2018
• Study Start: September 24, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2019
• Last Updated: June 9, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (7)