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OpenTrials
Completed

NCT Number: NCT01476397

Probiotic Formula and Infant Growth

This is a growth study of full-term, formula-fed infants randomized to receive a partially hydrolyzed whey protein formula with and without probiotics for the first four months of life. It is hypothesized that there will be no difference in growth between the two groups.

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Key information

Conditions

Healthy

Age range

11 day–17 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North Scottsdale Pediatric Associates, Scottsdale, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy newborn infant
  • Full-term
  • Birth weight > 2500 and < 4500 g
  • 14±3 days of age on enrollment
  • Exclusively formula-fed, singleton birth
  • Having obtained his/her legal representative's informed consent

Exclusion criteria

  • Known or suspected cow-milk allergy
  • Congenital illness or malformation that may affect infant feeding and/or growth
  • Significant prenatal and/or postnatal disease
  • Any readmission to hospital prior to enrollment
  • Receiving prescription medication or frequent use of over the counter medications except vitamin and mineral supplements
  • Has received intravenous antibiotic therapy or oral probiotic in the last 7 days
  • Currently participating in another clinical study
  • Cannot be expected to comply with treatment

Treatment and study plan

Control infant formula

Other

partially hydrolyzed whey infant formula consumed ad libitum throughout study

Test infant formula

Other

partially hydrolyzed whey formula with probiotic

Primary outcomes

  1. growth

    Time frame: 4 months

    weight gain assessed monthly

Secondary outcomes

  1. other growth

    Time frame: 4 months

    Length, head circumference will be measured at monthly visits

  2. adverse events

    Time frame: 4 months

    all adverse events will be documented throughout the study

  3. stool characteristics

    Time frame: throughout study

    stool frequency, color, consistency

  4. spit-up

    Time frame: throughout study

    frequency of spit-up as reported by caregivers

  5. vomit

    Time frame: throughout study

    frequency of vomitting as reported by caregivers

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study title

ASSESSMENT OF GROWTH OF INFANTS FED FORMULA WITH PROBIOTICS

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Nov 22, 2011
Registry last updated
Nov 4, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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