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Synbiotic Extensively Hydrolysed Feed Study

Primary Purpose

Cow Milk Allergy

Status
Active
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Extensively Hydrolysed Formula containing Pre- & Probiotics
Sponsored by
Nutricia UK Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cow Milk Allergy

Eligibility Criteria

undefined - 13 Months (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Brighton and Sussex University Hospital NHS Foundation Trust
  • University Hospitals Bristol NHS Foundation Trust
  • Ashford and St Peter's Hospital NHS Foundation Trust
  • Royal Surrey County Hospital NHS Foundation Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • The Rotherham NHS Foundation Trust
  • university Hospitals Southampton NHS Foundation Trust
  • West Hertfordshire NHS Foundation Trust

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Study product

Arm Description

Extensively Hydrolysed Formula containing Pre- and Probiotics

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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/
Food Allergy QOL - Parental burden questionnaire
Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire
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
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.
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
Change in weight
Weight will be measured at the start and end of the study in kg
Safety (Adverse Events)
Adverse events captured throughout entire study
Change in length (cm)
Length will be measured at the start and end of the study
Change in head circumference (cm)
Head circumference will be measured at the start and end of the study

Full Information

First Posted
November 23, 2018
Last Updated
April 12, 2022
Sponsor
Nutricia UK Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT03874104
Brief Title
Synbiotic Extensively Hydrolysed Feed Study
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
August 22, 2018 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
July 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nutricia UK Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cow Milk Allergy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Study product
Arm Type
Experimental
Arm Description
Extensively Hydrolysed Formula containing Pre- and Probiotics
Intervention Type
Dietary Supplement
Intervention Name(s)
Extensively Hydrolysed Formula containing Pre- & Probiotics
Intervention Description
Extensively Hydrolysed Formula containing Pre- and Probiotics
Primary Outcome Measure Information:
Title
Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire
Description
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
Time Frame
31 days
Secondary Outcome Measure Information:
Title
Compliance
Description
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.
Time Frame
31 days
Title
Parent-reported Atopic Symptoms
Description
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/
Time Frame
31 days
Title
Food Allergy QOL - Parental burden questionnaire
Description
Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire
Time Frame
31 days
Title
Formula acceptability: Likert-style questionnaire
Description
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
Time Frame
31 days
Title
Nutrient intake
Description
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.
Time Frame
31 days
Title
Atopic dermatitis severity
Description
Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study
Time Frame
31 days
Title
Change in weight
Description
Weight will be measured at the start and end of the study in kg
Time Frame
31 days
Title
Safety (Adverse Events)
Description
Adverse events captured throughout entire study
Time Frame
31 days
Title
Change in length (cm)
Description
Length will be measured at the start and end of the study
Time Frame
31 days
Title
Change in head circumference (cm)
Description
Head circumference will be measured at the start and end of the study
Time Frame
31 days

10. Eligibility

Sex
All
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Brighton and Sussex University Hospital NHS Foundation Trust
City
Brighton
Country
United Kingdom
Facility Name
University Hospitals Bristol NHS Foundation Trust
City
Bristol
Country
United Kingdom
Facility Name
Ashford and St Peter's Hospital NHS Foundation Trust
City
Chertsey
Country
United Kingdom
Facility Name
Royal Surrey County Hospital NHS Foundation Trust
City
Guildford
Country
United Kingdom
Facility Name
Guy's and St Thomas' NHS Foundation Trust
City
London
Country
United Kingdom
Facility Name
The Rotherham NHS Foundation Trust
City
Rotherham
Country
United Kingdom
Facility Name
university Hospitals Southampton NHS Foundation Trust
City
Southampton
Country
United Kingdom
Facility Name
West Hertfordshire NHS Foundation Trust
City
Watford
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

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Synbiotic Extensively Hydrolysed Feed Study

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