Synbiotics Cohort Study

Nutricia

Status: Terminated

Conditions: Cows Milk Allergy

Treatments: Other: Hypoallergenic formula containing synbiotics

Study type: Observational

Funder types: Industry

Identifiers

NCT05046418

HAFSYN21

Details and patient eligibility

About

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

Full description

A range of clinical outcomes will be collected from the medical records and in-person assessment of 60 fully or partially formula fed infants (aged <13 months) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of cow's milk allergy

Enrollment: 10 patients

Sex: All

Ages: Under 13 months old

Volunteers: No Healthy Volunteers

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

Trial design

10 participants in 1 patient group

Hypoallergenic formula containing synbiotics

Description:

Infants (aged \<13 months) with cow's milk allergy (CMA) who are prescribed a hypoallergenic formula containing synbiotics as part of usual clinical practice for the dietary management of CMA.

Treatment:

Other: Hypoallergenic formula containing synbiotics