Effects of an infant formula containing hydrolysed protein on growth, tolerance and safety in healthy term infants
| ISRCTN | ISRCTN86586050 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86586050 |
| Sponsor | Comac Medical |
| Funder | Valio |
- Submission date
- 06/07/2026
- Registration date
- 08/07/2026
- Last edited
- 08/07/2026
- Recruitment status
- Not yet recruiting
- Overall study status
- Ongoing
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
Background and study aims
In Europe, any infant formula made with hydrolysed proteins (proteins that have been broken down into smaller pieces) must be proven safe and appropriate through a clinical study before it can be sold, according to the European Food Safety Authority. The primary purpose of this study is to find out whether babies grow at the same rate when fed with a hydrolysed formula compared with a regular formula that contains whole milk protein. The study also looks at whether the formula made with hydrolysed proteins is safe for babies and how it affects common stomach and digestion problems.
Who can participate?
Healthy full-term infants aged up to 28 days
What does the study involve?
Participating infants are randomly allocated to two groups to receive either infant formula with hydrolysed proteins or ordinary infant formula with intact proteins for 3 months. Growth and the health status of the infant are followed and data on gastrointestinal symptoms is collected.
What are the possible benefits and risks of participating?
The participating infant may or may not benefit from this study in terms of growth, development, and gastrointestinal symptoms. The study can provide relevant evidence for future interventions and research in this field. No compensation for participating in this study is provided, but study products will be made available at no charge. The participating infant will also receive health checks including growth assessments at no cost.
A new formula may cause short-term gastrointestinal disturbances. Possible adverse events will be closely monitored during the study.
Where is the study run from?
Comac Medical Ltd (Bulgaria)
When is the study starting and how long is it expected to run for?
September 2026 to January 2028
Who is funding the study?
Valio Ltd (Finland)
Who is the main contact?
Dr Anu Turpeinen, anu.turpeinen@valio.fi
Contact information
Scientific
Valio Ltd, R&D, PO Box 30
Helsinki
00370
Finland
| Phone | +358 (0)503981108 |
|---|---|
| anu.turpeinen@valio.fi |
Public, Principal investigator
Comac Medical, Kula B, Mall Bulgaria, Manastirski Livadi, Bulgaria Blvd 69
Sofia
1404
Bulgaria
| Phone | +359 (0)28921000 |
|---|---|
| hayriye.tunca-ates@comac-medical.com |
Study information
| Primary study design | Interventional |
|---|---|
| Allocation | Randomized controlled trial |
| Masking | Blinded (masking used) |
| Control | Active |
| Assignment | Parallel |
| Purpose | Safety and suitability |
| Scientific title | Мulticenter, randomised, controlled, double-blind equivalence study to investigate the safety and suitability of a partially hydrolysed, cow’s milk based infant formula compared to cow’s milk-based infant formula with intact protein |
| Study acronym | NutriBaby |
| Study objectives | 1. The primary objective is to evaluate the equivalence between the hydrolysed formula and the infant formula with intact protein with respect to daily weight gain. 2. The secondary objective is to investigate effects of the partially hydrolysed formula on growth and gastrointestinal symptoms. |
| Ethics approval(s) |
Not yet submitted |
| Health condition(s) or problem(s) studied | Safety and suitability of a partially hydrolysed, cow’s milk based infant formula |
| Intervention | This study is a multicenter, randomised, controlled, double-blind equivalence study including two study arms: Arm 1 (test formula): partially hydrolysed, cow’s milk-based infant formula Arm 2 (control formula): a cow’s milk-based infant formula with intact protein Recruitment will be performed in five study sites in Bulgaria. Computer-generated randomisation lists are stratified by site and gender using random block sizes. The study is conducted in healthy, full-term, exclusively formula-fed infants. The total duration of the intervention for each participant is 3 months (approximately 90 days). Formulas are provided for free to the participating families in similar blank tins of 800 g powder. Formula consumption is ad libitum, but a feeding table instruction is provided with the parental information leaflet to guide and encourage the age-appropriate consumption of the supplied products. The study formulas are instructed to be used at every feeding. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
|
| Completion date | 31/01/2028 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Neonate |
| Lower age limit | 1 Day |
| Upper age limit | 28 Days |
| Sex | All |
| Target sample size at registration | 208 |
| Key inclusion criteria | 1. Gestational age 37+0 weeks – 42+0 weeks at birth 2. Birthweight between 2,500 and 4,500 g 3. Boys and girls 4. Healthy at birth and screening, e.g., major congenital anomalies, absence of serious illness requiring hospitalization, no metabolic or gastrointestinal conditions affecting growth or nutrition, stable vital signs. 5. Weight-for-age Z-score (WAZ), weight-for-length Z-score (WHZ), and length-for-age Z-score (LAZ) at screening within the normal range according to WHO Child Growth Standards (i.e., between −2 and 2) 6. Age at enrolment ≤28 days of age 7. Exclusively formula fed for at least 5 days prior to inclusion 8. Exclusively formula fed during the entire intervention period 9. Parents agreeing to initiate complementary feeding after finalization of the study 10. Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years |
| Key exclusion criteria | 1. Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMPA), lactose intolerance and diagnosed medical conditions that are known to affect growth, including severe gastroesophageal reflux (throwing up or spitting up more than a teaspoon of milk >8 times daily 2. Incapability of parents to comply with the study protocol 3. Inability to complete study diaries or comply with study procedures 4. Participation in another clinical trial 5. Unwillingness to accept the formula supplied by the study as the only formula for their child during study participation 6. Infants fed a special diet other than standard, non-hydrolysed, cow's or goat's milk based infant formula |
| Date of first enrolment | 01/09/2026 |
| Date of final enrolment | 31/10/2027 |
Locations
Countries of recruitment
- Bulgaria
Study participating centres
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
08/07/2026: Study's existence confirmed by Valio Ltd.
