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

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.

Study Overview

• Status: Completed
• Conditions: Cow Milk Allergy
• Intervention / Treatment: Dietary supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Brighton, United Kingdom
    • Brighton and Sussex University Hospital NHS Foundation Trust
  • Bristol, United Kingdom
    • University Hospitals Bristol NHS Foundation Trust
  • Chertsey, United Kingdom
    • Ashford and St Peter's Hospital NHS Foundation Trust
  • Guildford, United Kingdom
    • Royal Surrey County Hospital NHS Foundation Trust
  • London, United Kingdom
    • Guy's and St Thomas' NHS Foundation Trust
  • Rotherham, United Kingdom
    • The Rotherham NHS Foundation Trust
  • Southampton, United Kingdom
    • University Hospitals Southampton NHS Foundation Trust
  • Watford, United Kingdom
    • West Hertfordshire NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 1 year (Child)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Aged <13 months
• Currently using or requiring an extensively hydrolysed formula for the dietary management of cows' milk allergy
• Expected to receive at least 25% of their energy intake from the study feed
• Already fed with infant formula or hypoallergenic formula (either partially or fully)
• Written, informed consent from parent/carer

Exclusion Criteria:

• "Severe" cows' milk allergy (clinically judged to require an amino acid formula) or any other contraindications to the use of an extensively hydrolysed formula
• Exclusively breastfed infants
• Primary lactose intolerance
• History of poor tolerance to whey based EHFs
• Immunocompromised infants
• Premature infants (born <37 weeks)
• Major hepatic or renal dysfunction
• Requirement for any parenteral nutrition
• Tube-fed via a post-pyloric route
• Participation in other clinical intervention studies within 1 month of recruitment to this study
• Investigator concern around the ability of family to comply with protocol and requirements of study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study product; Extensively Hydrolysed Formula containing Pre- and Probiotics	Dietary supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics; Extensively Hydrolysed Formula containing Pre- and Probiotics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire	Gastro-intestinal tolerance will be recorded by the parent on Baseline Days 1-3 (where this period is undertaken by the patient) and on Intervention Days 1, 2, 3, 7, 14, 21, 26, 27, and 28. Tolerance will be recorded using a standardised gastro-intestinal tolerance questionnaire, to be completed by the parents/carer	31 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	Compliance with feed prescription will be assessed daily throughout the study by recording how much feed was received. The amount prescribed by the Dietitian will be recorded at the start of the study, and any changes to this prescription also noted. During the baseline period (where this is undertaken) the compliance of the patient's usual feed will be assessed.	31 days
Parent-reported Atopic Symptoms	Recorded via visual analogue scales at baseline and at the end of each week. Parents will record on a 100mm line the severity of a number of common atopic symtpoms, with the scale running from "not at all/none" at 0mm and "as bad as possible/	31 days
Food Allergy QOL - Parental burden questionnaire	Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire	31 days
Formula acceptability: Likert-style questionnaire	Feed acceptability will be assessed on Baseline Day 3 (for current feed, where applicable) and on the final day of the intervention period (Intervention day 28) via a Likert-style questionnaire	31 days
Nutrient intake	Nutrient intake, including the intake of all nutrition provided (including the study product, any other enteral tube feeding, foods, drinks etc.) will be recorded via a 24hr dietary recall, conducted by the Dietitian at the Baseline Visit and at the End of Study Visit.	31 days
Atopic dermatitis severity	Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study	31 days
Change in weight	Weight will be measured at the start and end of the study in kg	31 days
Safety (Adverse Events)	Adverse events captured throughout entire study	31 days
Change in length (cm)	Length will be measured at the start and end of the study	31 days
Change in head circumference (cm)	Head circumference will be measured at the start and end of the study	31 days

Collaborators and Investigators

• Sponsor: Nutricia UK Ltd

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 2018
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): July 31, 2023

Study Registration Dates

• First Submitted: November 23, 2018
• First Submitted That Met QC Criteria: March 13, 2019
• First Posted (Actual): March 14, 2019

Study Record Updates

• Last Update Posted (Actual): November 27, 2023
• Last Update Submitted That Met QC Criteria: November 24, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Food Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Milk Hypersensitivity
• Other Study ID Numbers: PEPSYN001 V6

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No