Clinical trial NCT05868408: Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants
Official title: Effect of Partially Hydrolyzed, Whey-based Infant Formulas on Growth and Tolerability in Healthy Term Infants: a Double-blind, Randomized, Controlled, Multi-arm Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infant Nutritional Physiological Phenomena
Infant Formula
Infant Health
Infant Development
Growth and Development
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2023-05-22
Enrollment: 234
Sex: ALL
Minimum age (years): 0
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blind, randomized, controlled, multi-arm trial
Primary purpose: OTHER

Brief 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 Criteria:

1. Written informed consent has been obtained from at least one parent (or other legally acceptable 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 longer breastfeeding or receiving breast milk
7. Infant's parent(s)/LAR is of legal age of majority, must understand the informed consent form and other relevant study documents, and is willing and able to fulfill the requirements of the study protocol

Exclusion Criteria:

1. Chronic infectious, metabolic, genetic illness or other disease, including any condition that impacts feeding or growth
2. Major congenital or chromosomal abnormality known to affect growth (e.g., congenital heart disease, cystic fibrosis)
3. Maternal medical conditions known to affect infant growth (e.g., untreated preeclampsia 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 the investigator, would make the child inappropriate for entry into the study
7. Currently participating or having participated in another interventional clinical trial prior to enrollment

Primary outcomes:
measure: Difference in growth in first 4 months of life between control and experimental groups
timeFrame: From enrollment to age 4 months
measure: Equivalence in growth in first 4 months of life in experimental groups
timeFrame: From enrollment to age 4 months
Secondary outcomes:
measure: Gastrointestinal (GI) tolerance
timeFrame: Enrollment and age 4, 6, and 12 months
measure: Stooling pattern
timeFrame: Age 2 and 4 months
measure: Atopic dermatitis severity
timeFrame: Enrollment and age 4, 6, and 12 months
measure: Allergy-related symptoms
timeFrame: Enrollment and age 4, 6, and 12 months
measure: Dietary intake
timeFrame: Age 6 months
measure: Weight
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Length
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Head circumference
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Weight-for-age z-score
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Weight-for-length z-score
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Length-for-age z-score
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
measure: Head circumference-for-age z-score
timeFrame: Enrollment and age 1, 2, 3, 4, and 6 months
Other outcomes:
measure: Stool microbiota composition
timeFrame: Age 4 months
measure: Stool microbiota metabolism
timeFrame: Age 4 months
measure: Fecal peptides
timeFrame: Age 4 months
measure: Urinary metabolomic profile
timeFrame: Age 4 months
Locations:
city: Jeddah
country: Saudi Arabia
facility: National Guard Hospital
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital and Research Center
city: Riyadh
country: Saudi Arabia
facility: National Guard Hospital
Study officials:
References: