Growth and Tolerance Trial on Infant Formula With HMO

NCT04066413 | Terminated DMC

• 1 other identifier: Stardust
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to compare growth of healthy infants fed an infant formula supplemented with a human milk oligosaccharide to that of infants on standard formula.

Conditions

Healthy Growth

Keywords

infant formula; human milk oligosaccharide; HMO; growth

Outcome Measures

Primary Outcomes (1)

• Growth

  Infant growth measured as body weight gain per day

  From enrollment until end of the 3 month-study

Secondary Outcomes (6)

• Weight

  Monthly, from enrollment until end of the 3 month-study

• Recumbent length

  Monthly, from enrollment until end of the 3 month-study

• Head circumference

  Monthly, from enrollment until end of the 3 month-study

• Anthropometry z-scores

  Monthly, from enrollment until end of the 3 month-study

• Formula tolerance

  Monthly, from enrollment until end of the 3 month-study

Study Arms (3)

Breastfed group

NO INTERVENTION

Non-randomized breastfed reference group

Control formula

PLACEBO COMPARATOR

Group receiving standard infant formula

Other: Standard infant formula

Formula with HMO

ACTIVE COMPARATOR

Group receiving standard infant formula supplemented with HMO

Other: Infant formula supplemented with HMO

Interventions

Standard infant formula OTHER

Standard infant formula

Control formula

Infant formula supplemented with HMO OTHER

Infant formula supplemented with HMO

Formula with HMO

Eligibility Criteria

• Age: Up to 1 Month
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Gestational age ≥ 37 weeks
• Birth weight ≥ 2500 grams
• No recognized diseases (such as cardiac, pulmonary, gastrointestinal, renal or genetic diseases)
• Boys and girls
• Recruited \< 1 month/age
• Being available for follow up until the age of 4 months
• Exclusive formula feeding or exclusive breast feeding at time of recruitment

You may not qualify if:

• Gestational age \<37 weeks
• Birth weight \<2500 grams
• Severe acquired or congenital diseases, mental or physical disorders
• Incapability of parents/caregivers to comply with the study protocol
• Received antibiotics within the first month of life
• Not tolerating standard cow's milk based infant formula
• Participation in another clinical trial
• Maternal illicit drug use during pregnancy or post-partum period
• Parent/caregiver does not have a cell phone to use for filling out questionnaires

Sponsors & Collaborators

• FrieslandCampina: lead

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229-3026, United States

Location

MeSH Terms

Interventions

Health Maintenance Organizations

Intervention Hierarchy (Ancestors)

Managed Care Programs; Insurance, Health; Insurance; Financing, Organized; Economics; Health Care Economics and Organizations; Prepaid Health Plans; Group Practice; Professional Practice; Organization and Administration; Health Services Administration; Delivery of Health Care; Patient Care Management

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: August 26, 2019
• Study Start: September 23, 2019
• Primary Completion: January 26, 2023
• Study Completion: January 26, 2023
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)