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

Infant Development Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05868408
• Other study ID #: 21.10.INF
• Status: Recruiting
• Phase: N/A
• Start date: August 17, 2023
• Est. completion date: July 2025

Study information

• Verified date: October 2023
• Source: Société des Produits Nestlé (SPN)
• Contact: Anthony de Cozar
• Phone: +41 21 785 8573
• Email: anthony.decozar[@]rd.nestle.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: July 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 0 Days to 28 Days

Eligibility

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

Related Conditions & MeSH terms

• Growth and Development
• Infant Development
• Infant Formula
• Infant Health
• Infant Nutritional Physiological Phenomena

Intervention

Other:
• Control Formula
Infant formula made with intact protein - minimum 1.8g protein/100kcal
• Experimental Formula 1
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal
• Experimental Formula 2
Infant formula made with hydrolyzed protein - minimum 1.9g protein/100kcal

Locations

Country	Name	City	State
Saudi Arabia	National Guard Hospital	Jeddah
Saudi Arabia	King Faisal Specialist Hospital and Research Center	Riyadh
Saudi Arabia	National Guard Hospital	Riyadh

Sponsors (1)

Lead Sponsor	Collaborator
Société des Produits Nestlé (SPN)

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Stool microbiota composition	Stool microbiota composition assessed using shotgun metagenomic analysis	Age 4 months
Other	Stool microbiota metabolism	Stool organic acids and other metabolites	Age 4 months
Other	Fecal peptides	Fecal milk-derived peptides	Age 4 months
Other	Urinary metabolomic profile	Untargeted analysis of urine metabolites by H1-nuclear magnetic resonance (NMR) spectroscopy	Age 4 months
Primary	Difference in growth in first 4 months of life between control and experimental groups	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).	From enrollment to age 4 months
Primary	Equivalence in growth in first 4 months of life in experimental groups	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).	From enrollment to age 4 months
Secondary	Gastrointestinal (GI) tolerance	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.	Enrollment and age 4, 6, and 12 months
Secondary	Stooling pattern	Stool frequency and consistency assessed using a 3-day infant stool diary.	Age 2 and 4 months
Secondary	Atopic dermatitis severity	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.	Enrollment and age 4, 6, and 12 months
Secondary	Allergy-related symptoms	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.	Enrollment and age 4, 6, and 12 months
Secondary	Dietary intake	Total energy and macronutrient intake calculated from food recalls / diaries	Age 6 months
Secondary	Weight	Weight (g)	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Length	Length (cm)	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Head circumference	Head circumference (cm)	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Weight-for-age z-score	Weight-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Weight-for-length z-score	Weight-for-length z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Length-for-age z-score	Length-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months
Secondary	Head circumference-for-age z-score	Head circumference-for-age z-score based on World Health Organization (WHO) and Saudi Arabian growth charts.	Enrollment and age 1, 2, 3, 4, and 6 months