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Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

NCT ID: NCT05578716

Last Updated: 2023-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

312 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-03

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infant Formula

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Study formula 1

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

Group Type EXPERIMENTAL

Partially hydrolysed formula

Intervention Type DIETARY_SUPPLEMENT

Partially hydrolysed formula

Study formula 2

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

Group Type EXPERIMENTAL

Partially hydrolysed formula

Intervention Type DIETARY_SUPPLEMENT

Partially hydrolysed formula

Standard formula

Formula-fed control group randomised to standard formula

Group Type NO_INTERVENTION

No interventions assigned to this group

Breast feeding

Reference group with exclusively breast-fed infants

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Partially hydrolysed formula

Partially hydrolysed formula

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* Suspected or verified food allergy
* Suspected or verified infant colic
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

8 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Arla Foods

INDUSTRY

Sponsor Role collaborator

Umeå University

OTHER

Sponsor Role lead

Responsible Party

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Magnus Domellöf

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Magnus Domellöf, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Locations

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Department of clinical science, Preventive Paediatrics, Lund university

Malmo, , Sweden

Site Status RECRUITING

Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Umeå, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Magnus Domellöf, MD, PhD

Role: CONTACT

Phone: +46907852128

Email: [email protected]

Facility Contacts

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Pia Karlsland-Akeson, MD, PhD

Role: primary

Magnus Domellöf, MD, PhD

Role: primary

Other Identifiers

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20210707401

Identifier Type: -

Identifier Source: org_study_id