CompletedNot Applicable

Low-protein Infant Formula With Partial or Extensive Proteinhydrolysate 4 Year Follow-up

Austria, Germany, Serbia503 participantsStarted 2010-04

Plain-language summary

The study is conducted to examine the suitability of partially respectively extensively hydrolyzed low protein infant formulae with and without pro- and prebiotics for healthy, term infants. Primary hypothesis to be tested is: an infant formula based on a Protein hydrolysate with modified protein content is non inferior compared to a standard infant formula based on a Protein hyrolysate in respect to proper growth of healthy, term infants within the first four month of life. 4-year follow-up (without further Intervention) will focus on body composition and allergic predisposition.

Who can participate

Age range

1 Day – 27 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * written informed consent (by parents, caregiver) * Healthy term newborns (gestational age: ≥ 37 weeks) * Birth weight between 2.500 - 4.500 g * Age at enrolment: \< 28 days of age * Infant received no other formula since birth * Parents / Caregivers are able to speak German Exclusion Criteria: * Severe acquired or congenital illness * preterm infants (gestational age \< 37 weeks) * Birth weight lower than 2.500 g or higher than 4.500 g * Feeding a cows milk based formula or any other formula prior to inclusion in this study * Participation in any other clinical study intervention * Regular intake of supplementary pre- and probiotics by the child and/or breastfeeding mother * Mothers with diabetes mellitus or mothers suffered from gestational diabetes * Founded assumption that it will not be possible for parents / caregivers to be compliant with the study protocol * Breastfed infants: illness of the mother, that may have an influence on the gastrointestinal tract of the child * Breastfed infants: mother receives or received antibiotics one week before inclusion in this study or during the first study phase

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

average weight gain

Timeframe: 4 months

Trial details

NCT IDNCT01143233

SponsorHiPP GmbH & Co. Vertrieb KG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2014-07

View on ClinicalTrials.gov More Disturbance of Growth trials