Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants

Last updated: October 5, 2023
Sponsor: Société des Produits Nestlé (SPN)
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pediatric Health

Treatment

Experimental Formula 1

Control Formula

Experimental Formula 2

Clinical Study ID

NCT05868408
21.10.INF
  • Ages < 28
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This study will assess the effect of partially hydrolyzed, whey-based infant formulas on growth and gastrointestinal tolerance in healthy term infants.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent has been obtained from at least one parent (or other legallyacceptable representative [LAR]), if applicable)
  2. Infant gestational age ≥37 completed weeks
  3. Infant birth weight of ≥2.5 kg and ≤4.5 kg
  4. Singleton birth
  5. Infant postnatal age ≤28 days (date of birth = day 0)
  6. Mother has previously decided to fully formula-feed, and infant is no longerbreastfeeding or receiving breast milk
  7. Infant's parent(s)/LAR is of legal age of majority, must understand the informedconsent form and other relevant study documents, and is willing and able to fulfillthe requirements of the study protocol

Exclusion

Exclusion Criteria:

  1. Chronic infectious, metabolic, genetic illness or other disease, including anycondition that impacts feeding or growth
  2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenitalheart disease, cystic fibrosis)
  3. Maternal medical conditions known to affect infant growth (e.g., untreatedpreeclampsia or gestational diabetes)
  4. Infants with special dietary needs other than standard infant formula
  5. Infants with known (or symptoms suggestive of) cow's milk protein intolerance/allergy,or lactose intolerance or severe food allergies that impact diet
  6. Child has other medical or psychiatric condition that, in the judgement of theinvestigator, would make the child inappropriate for entry into the study
  7. Currently participating or having participated in another interventional clinicaltrial prior to enrollment

Study Design

Total Participants: 234
Treatment Group(s): 3
Primary Treatment: Experimental Formula 1
Phase:
Study Start date:
August 17, 2023
Estimated Completion Date:
July 31, 2025

Connect with a study center

  • National Guard Hospital

    Jeddah,
    Saudi Arabia

    Active - Recruiting

  • King Faisal Specialist Hospital and Research Center

    Riyadh,
    Saudi Arabia

    Site Not Available

  • National Guard Hospital

    Riyadh,
    Saudi Arabia

    Active - Recruiting

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