FARE - Food Allergy Research & Education Logo

Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Eligible Ages 4 Weeks - 8 Weeks
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.


Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Umeå University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Magnus Domellöf, MD, PhD
Principal Investigator Affiliation Department of Clinical Sciences, Pediatrics, Umeå University Hospital
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Sweden

The disease, disorder, syndrome, illness, or injury that is being studied.

Infant Formula
Arms & Interventions


Experimental: Study formula 1

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

Experimental: Study formula 2

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

No Intervention: Standard formula

Formula-fed control group randomised to standard formula

No Intervention: Breast feeding

Reference group with exclusively breast-fed infants


Dietary Supplement: - Partially hydrolysed formula

Partially hydrolysed formula

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Malmö, Sweden




Department of clinical science, Preventive Paediatrics, Lund university

Malmö, , 20502

Site Contact

Pia Karlsland-Akeson, MD, PhD



Umeå, Sweden




Department of Clinical Sciences, Pediatrics, Umeå University Hospital

Umeå, , 901 85

Site Contact

Magnus Domellöf, MD, PhD


0046 90 7852128

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.