Synbiotics Cohort Study (NCT05046418) | Clinical Trial Compass
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 range0 Months – 13 Months
SexALL
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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