Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, T… (NCT06137235) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Effects of an Infant Formula and follow-on Formula Containing Bio-active Ingredients on Growth, Tolerance and Infections
Greece456 participantsStarted 2023-12-18
Plain-language summary
In this clinical trial, the growth (weight for age), product tolerance (product intake, comfort) and infection-related symptoms of healthy infants consuming an IF and FOF containing bio-active ingredients will be evaluated and compared to a group of infants consuming a standard IF and FOF.
Who can participate
Age range
5 Days – 60 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:
* Full-term infants
* Healthy birthweight: 2500 g ≤ birthweight ≤ 4200 g
* Boys and girls
* Apparently healthy at birth and screening
* Weight-for-age Z-score (WAZ) at screening within the normal range according to WHO Child Growth Standards
* Age at enrolment: ≤60 days of age
* If age at inclusion ≤1 month: infants exclusively formula fed for at least 5 days prior to inclusion
* If 1 month \< age at inclusion ≤ 2 months: infants exclusively formula fed since 1 month old2
* Being available for follow up until the age of 12 months
* Written informed consent from parent(s) and/or legal guardian(s) aged ≥18 years
Exclusion Criteria:
* Severe acquired or congenital diseases, mental or physical disorders, including cow's milk protein allergy (CMA), lactose intolerance and diagnosed medical conditions that are known to affect study outcomes (e.g. functional gastro-intestinal disorders (FGID))
* Incapability of parents to comply with the study protocol
* Illiterate parents (i.e. not able to read and write in local language)
* Participation in another clinical trial
* Unwillingness to accept the formula supplied by the study as the only formula for their child until the age of 12 months
* Infants fed a special diet other than standard cow's or goat's milk based (non-hydrolyzed) infant formula prior to inclusion
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.