CompletedNot Applicable

Feeding Infant Formula With Added Probiotics and Whey Protein Concentrate

China800 participantsStarted 2012-12

Plain-language summary

To evaluate the effects of feeding an infant formula containing L. paracasei ssp. paracasei strain F19 or Whey Protein Concentrate.

Who can participate

Age range

2 Weeks

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 (formula-fed group): healthy infants of mothers who could not or voluntarily resigned completely from breast-feeding at infant age 14 plus/minus 3 days Inclusion criteria (breast-fed group): healthy infants exclusively breast-fed from birth and mothers intending to breastfeed \>80% until at least 5th month of age (meaning through the 4th month of age). Inclusion criteria (all infants): delivered between 37 and 42 weeks of gestation birth weight \>2500 g and \<4000 g parent or the subject's legal representative speak and understand Chinese Exclusion criteria (formula-fed group): fully or partially breast-fed infants infants breast-fed \>20% Exclusion criteria (breast-fed group): infants fed \>20% infant formula Exclusion criteria (all infants): malformations, handicaps or congenital diseases that could affect normal feeding or growth treatment with antibiotics

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

Infections episodes (gastrointestinal and upper and lower respiratory infections)

Timeframe: 4 yrs

Trial details

NCT IDNCT01755481

SponsorArla Foods

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-08

View on ClinicalTrials.gov More Focus on Healthy Infants trials

Who can participate

Age range

2 Weeks

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.