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Synbiotic Extensively Hydrolysed Feed Study

NCT03874104 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2023-11-27

No results posted yet for this study

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

DIETARY_SUPPLEMENT

Extensively Hydrolysed Formula containing Pre- & Probiotics

Extensively Hydrolysed Formula containing Pre- and Probiotics

Sponsors & Collaborators

  • Nutricia UK Ltd

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
13 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-22
Primary Completion
2021-12-01
Completion
2023-07-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03874104 on ClinicalTrials.gov