NCT03874104

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 23, 2018

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 14, 2019

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2023

Completed
Last Updated

November 27, 2023

Status Verified

November 1, 2023

Enrollment Period

3.3 years

First QC Date

November 23, 2018

Last Update Submit

November 24, 2023

Conditions

Cow Milk Allergy

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Compliance

    31 days

  • Parent-reported Atopic Symptoms

    31 days

  • Food Allergy QOL - Parental burden questionnaire

    31 days

  • Formula acceptability: Likert-style questionnaire

    31 days

  • Nutrient intake

    31 days

  • +5 more secondary outcomes

Study Arms (1)

Study product

EXPERIMENTAL

Extensively Hydrolysed Formula containing Pre- and Probiotics

Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics

Interventions

Extensively Hydrolysed Formula containing Pre- & ProbioticsDIETARY_SUPPLEMENT

Extensively Hydrolysed Formula containing Pre- and Probiotics

Study product

Eligibility Criteria

AgeUp to 13 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • "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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Brighton and Sussex University Hospital NHS Foundation Trust

Brighton, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Location

Ashford and St Peter's Hospital NHS Foundation Trust

Chertsey, United Kingdom

Location

Royal Surrey County Hospital NHS Foundation Trust

Guildford, United Kingdom

Location

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

Location

The Rotherham NHS Foundation Trust

Rotherham, United Kingdom

Location

university Hospitals Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

West Hertfordshire NHS Foundation Trust

Watford, United Kingdom

Location

MeSH Terms

Conditions

Milk Hypersensitivity

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Food HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

Dietary SupplementsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 23, 2018

First Posted

March 14, 2019

Study Start

August 22, 2018

Primary Completion

December 1, 2021

Study Completion

July 31, 2023

Last Updated

November 27, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

GB(8)