Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

NCT05578716 | Recruiting

• 1 other identifier: 20210707401
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 2

Brief Summary

Breastfeeding is the recommended diet for all infants during the first half of infancy and is associated with numerous health benefits. However, when breastfeeding is not possible, an infant formula is the only nutritive alternative. Formula-fed infants have a different growth pattern compared to breastfed infants. Studies have shown that the higher protein content in infant formula compared to breastmilk results in a more rapid weight gain and an increased risk of overweight and obesity in childhood. For this reason, both quantity and quality of protein in infant formulae have been optimized during the last decade, to better meet the needs of infants and to support growth close to that of breastfed infants. Protein hydrolysis, a common modification of infant formulae, has originally been developed for treatment of cow's milk protein allergy. Certain hydrolysed formulae have been suggested to prevent atopic eczema when given to infants with a family history of allergic disease but as of yet, the allergy preventive effect in infants without increased risk of allergic disease has been little studied. Partially hydrolysed infant formulae have also been suggested to reduce common functional gastrointestinal symptoms in infants. New protein hydrolysates are continually developed for use in infant formulae, with the aim of reducing allergenicity, while ensuring optimal growth and development of infants. It is important to study the effects on growth and health outcomes in infants who are fed formulae based on these newly developed hydrolysates as compared to those fed standard intact protein formulae or breastmilk. The overall aims of the current study are to evaluate the effects of two new hydrolysates on growth, immunological biomarkers, neurodevelopment, protein metabolism and gut microbiota in a randomized, controlled clinical trial of healthy infants. In compliance with European Food Safety Authority (EFSA) regulations for novel infant formulas based on hydrolysed protein, the primary outcome is change in weight standard deviation score (SDS) from baseline until 5 months of age.

Conditions

Infant Formula

Keywords

Infant nutrition; Food hypersensitivity; Dermatitis, Atopic; Protein hydrolysates; Spectroscopy, Near-Infrared

Outcome Measures

Primary Outcomes (1)

• Weight

  Primary outcome is weight Standard Deviation Score (SDS) at the end of the intervention.

  At 5 months of age

Secondary Outcomes (15)

• Length.

  At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.

• Head circumference.

  At enrollment at 2 months of age and monthly during the intervention up to 5 months of age.

• Body composition

  At 4 months of age

• Gastrointestinal tolerance.

  At enrollment at 2 months of age and during the intervention up to 5 months of age.

• Gastrointestinal immunology.

  At enrollment at 2 months of age and during the intervention up to 5 months of age.

Study Arms (4)

Study formula 1

EXPERIMENTAL

Formula-fed intervention group randomised to one of two study formulae

Dietary Supplement: Partially hydrolysed formula

Study formula 2

EXPERIMENTAL

Formula-fed intervention group randomised to one of two study formulae

Dietary Supplement: Partially hydrolysed formula

Standard formula

NO INTERVENTION

Formula-fed control group randomised to standard formula

Breast feeding

NO INTERVENTION

Reference group with exclusively breast-fed infants

Interventions

Partially hydrolysed formula DIETARY_SUPPLEMENT

Partially hydrolysed formula

Study formula 1; Study formula 2

Eligibility Criteria

• Age: 4 Weeks - 8 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy infants born at term
• Birth weight 2500 to 4500 gram
• Either exclusive breast-feeding (reference group) or exclusive formula-feeding (intervention and control group)

You may not qualify if:

• Suspected or verified food allergy
• Suspected or verified infant colic

Sponsors & Collaborators

• Umeå University: lead
• Lund University: collaborator
• Arla Foods: collaborator

Study Sites (2)

Department of clinical science, Preventive Paediatrics, Lund university

Malmo, 20502, Sweden

RECRUITING

Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Umeå, 901 85, Sweden

RECRUITING

MeSH Terms

Conditions

Food Hypersensitivity; Dermatitis, Atopic

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Magnus Domellöf, MD, PhD

  Department of Clinical Sciences, Pediatrics, Umeå University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magnus Domellöf, MD, PhD

CONTACT

+46907852128; magnus.domellof@umu.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Each formula in the study will have the same packaging besides from colour coding (green, blue, yellow). None of the study personnel are aware of which colour represents which formulae during the course of the intervention.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Participants will be randomised to either standard formula or one of two partially hydrolysed study formulae. Included in the study will also be a group of breast-fed infants acting as reference group.

Study Record Dates

• First Submitted: September 19, 2022
• First Posted: October 13, 2022
• Study Start: October 3, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: December 12, 2023

Record last verified: 2023-12

Locations

SE (2)