TerminatedNot Applicable

Synbiotics Cohort Study

Stopped: Poor recruitment

United Kingdom10 participantsStarted 2021-09-05

Plain-language summary

Observational study exploring the clinical outcomes of infants with cow's milk allergy who are prescribed a hypoallergenic formula containing synbiotics.

Who can participate

Age range

0 Months – 13 Months

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: * Aged \<13 months * Confirmed or suspected CMA- based on healthcare professional (HCP) judgement * At baseline, parent(s) must already be exclusively or partially formula feeding their child (with a hypoallergenic or non-hypoallergenic formula) or have already made the decision to start exclusively or partially formula feeding * Recently prescribed a hypoallergenic formula containing synbiotics Exclusion Criteria: * Exclusively breastfed infants * Primary lactose intolerance * Enterally fed infants * Premature infants (born \<37 weeks) with a corrected age of less than 1 month * Infants with contraindications to the use of hyopallergenic formula containing synbiotics * Major hepatic or renal dysfunction * Investigator concern around the ability of family to comply with protocol and requirements of study

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

Healthcare use

Timeframe: 6 months

Trial details

NCT IDNCT05046418

SponsorNutricia UK Ltd

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Cows Milk Allergy trials

Who can participate

Age range

0 Months – 13 Months

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.