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

Not Applicable

Recruiting

• Conditions: Infant Nutritional Physiological Phenomena; Infant Formula; Infant Health; Infant Development; Growth and Development
• Interventions: Other: Experimental Formula 2; Other: Control Formula; Other: Experimental Formula 1

• Registration Number: NCT05868408
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-16
• Study First Submitted QC: 2023-05-11
• Study First Posted: 2023-05-22
• Study Start: 2023-08-17
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-05
• Last Update Posted: 2023-10-10
• Primary Completion: 2024-10
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 234

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental formula 2	Experimental Formula 2	EXPL2, an infant formula identical to EXPL1 but manufactured using a different partially hydrolyzed milk protein base
Control formula	Control Formula	CTRL, an infant formula with minimum protein content of 1.8g intact protein/100kcal
Experimental formula 1	Experimental Formula 1	EXPL1, an infant formula with minimum protein content of 1.9g hydrolyzed protein/100kcal

Primary Outcome Measures

Name	Time	Method
Difference in growth in first 4 months of life between control and experimental groups	From enrollment to age 4 months	To demonstrate that growth from enrollment to age 4 months of infants fed experimental formula 1 (EXPL1) or experimental formula 2 (EXPL2) is non-inferior to that of infants fed control formula (CTRL). This is measured by weight gain velocity (g/day).
Equivalence in growth in first 4 months of life in experimental groups	From enrollment to age 4 months	To demonstrate that growth from enrollment to age 4 months is equivalent between infants fed EXPL1 or EXPL2. This is measured by weight gain velocity (g/day).

Secondary Outcome Measures

Name	Time	Method
Atopic dermatitis severity	Enrollment and age 4, 6, and 12 months	Atopic dermatitis severity assessed using the Patient Oriented Eczema Measure (POEM). POEM scores range from 0 to 28, with lower scores indicating lower atopic dermatitis severity.
Stooling pattern	Age 2 and 4 months	Stool frequency and consistency assessed using a 3-day infant stool diary.
Dietary intake	Age 6 months	Total energy and macronutrient intake calculated from food recalls / diaries
Weight	Enrollment and age 1, 2, 3, 4, and 6 months	Weight (g)
Head circumference-for-age z-score	Enrollment and age 1, 2, 3, 4, and 6 months	Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Gastrointestinal (GI) tolerance	Enrollment and age 4, 6, and 12 months	GI tolerance assessed using the Infant Gastrointestinal Symptom Questionnaire (IGSQ). IGSQ scores range from 13 to 65, with lower scores indicating lower GI symptom burden.
Head circumference	Enrollment and age 1, 2, 3, 4, and 6 months	Head circumference (cm)
Allergy-related symptoms	Enrollment and age 4, 6, and 12 months	Allergy-related symptoms assessed using the Multi-Organ System Questionnaire for Infants (MOSQ-I). MOSQ-I scores range from 0 to 105, with lower scores indicating lower allergy-related symptom burden.
Length	Enrollment and age 1, 2, 3, 4, and 6 months	Length (cm)
Weight-for-age z-score	Enrollment and age 1, 2, 3, 4, and 6 months	Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Weight-for-length z-score	Enrollment and age 1, 2, 3, 4, and 6 months	Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.
Length-for-age z-score	Enrollment and age 1, 2, 3, 4, and 6 months	Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.

Trial Locations

Locations (2)

King Faisal Specialist Hospital and Research Center; 🇸🇦 Riyadh, Saudi Arabia

National Guard Hospital; 🇸🇦 Riyadh, Saudi Arabia