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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
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.
Age
0 - 1 years
Sex
ALL
Healthy Volunteers
No
Brighton and Sussex University Hospital NHS Foundation Trust
Brighton, United Kingdom
University Hospitals Bristol NHS Foundation Trust
Bristol, United Kingdom
Ashford and St Peter's Hospital NHS Foundation Trust
Chertsey, United Kingdom
Royal Surrey County Hospital NHS Foundation Trust
Guildford, United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom
The Rotherham NHS Foundation Trust
Rotherham, United Kingdom
university Hospitals Southampton NHS Foundation Trust
Southampton, United Kingdom
West Hertfordshire NHS Foundation Trust
Watford, United Kingdom
Start Date
August 22, 2018
Primary Completion Date
December 1, 2021
Completion Date
July 31, 2023
Last Updated
November 27, 2023
35
ACTUAL participants
Extensively Hydrolysed Formula containing Pre- & Probiotics
DIETARY_SUPPLEMENT
Lead Sponsor
Nutricia UK Ltd
NCT05785299
NCT04249973
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT04184700