Effects of hydrolysed infant formula on growth and allergies
GRANDIOSA - Growth, Allergy and Neurodevelopment in Infants on Hydrolysed Formula
This study tests whether a special type of baby formula can help healthy infants grow better and reduce their chances of developing allergies compared to those who are exclusively breastfed.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 312 (estimated) |
| Ages | 4 Weeks to 8 Weeks |
| Sex | All |
| Sponsor | Umeå University Academic / other |
| Locations | 2 sites (Malmö and 1 other locations) |
| Trial ID | NCT05578716 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of partially hydrolysed infant formula on growth patterns and the development of allergies in healthy infants. It compares infants who are exclusively breastfed with those who are exclusively formula-fed, focusing on how different protein compositions in the formula affect growth and the risk of atopic conditions. The study aims to optimize infant nutrition by assessing the benefits of hydrolysed formulas, particularly for those with a family history of allergies. The methodology includes monitoring growth metrics and allergy development over time.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy infants born at term with a birth weight between 2500 to 4500 grams.
Not a fit: Patients with suspected or verified food allergies or infant colic may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved infant nutrition strategies that reduce the risk of allergies and promote healthier growth patterns.
How similar studies have performed: Previous studies have suggested that hydrolysed formulas may prevent atopic eczema in infants with a family history of allergies, indicating potential success in similar approaches.
Eligibility criteria
Show full 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
Where this trial is running
Malmö and 1 other locations
- Department of clinical science, Preventive Paediatrics, Lund university — Malmö, Sweden (Recruiting)
- Department of Clinical Sciences, Pediatrics, Umeå University Hospital — Umeå, Sweden (Recruiting)
Study contacts
- Principal investigator: Magnus Domellöf, MD, PhD — Department of Clinical Sciences, Pediatrics, Umeå University Hospital
- Study coordinator: Magnus Domellöf, MD, PhD
- Email: magnus.domellof@umu.se
- Phone: +46907852128
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.