NCT03874104

Synbiotic Extensively Hydrolysed Feed Study

An Evaluation of the Tolerance and Acceptability of a Whey-based Extensively Hydrolysed Feed With Pre- and Probiotics, for the Dietary Management of Cows' Milk Allergy in Infants

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Nutricia UK Ltd · Industry
• Sex: All
• Age: 13 Months
• Healthy volunteers: Not accepted

Summary

This study of the tolerance and acceptability of a extensively hydrolysed formula (eHF) containing pre- and probiotics will assess gastrointestinal (GI) tolerance, product intake and acceptability in 40 infants (aged \<13 months) currently using or requiring an extensively hydrolysed formula for the dietary management of CMA. Patients already prescribed an eHF (or other appropriate feed for CMA) at time of recruitment will undertake a 3 day baseline period in which their current symptoms, compliance, GI tolerance and acceptability towards their current feed is assessed, before introducing the study product for a period of 4 weeks. Patients who are not on an eHF (or other appropriate feed for CMA) at baseline will forgo this 3 day baseline period and immediately introduce the study product for 4 weeks.

Conditions

• Cow Milk Allergy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Extensively Hydrolysed Formula containing Pre- & Probiotics	Extensively Hydrolysed Formula containing Pre- and Probiotics

Timeline

• Start date: 2018-08-22
• Primary completion: 2021-12-01
• Completion: 2023-07-31
• First posted: 2019-03-14
• Last updated: 2023-11-27

Locations

8 sites across 1 country: United Kingdom