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Synbiotic Extensively Hydrolysed Feed Study

NCT ID: NCT03874104

Last Updated: 2023-11-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-22

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cow Milk Allergy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Study product

Extensively Hydrolysed Formula containing Pre- and Probiotics

Group Type EXPERIMENTAL

Extensively Hydrolysed Formula containing Pre- & Probiotics

Intervention Type DIETARY_SUPPLEMENT

Extensively Hydrolysed Formula containing Pre- and Probiotics

Interventions

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Extensively Hydrolysed Formula containing Pre- & Probiotics

Extensively Hydrolysed Formula containing Pre- and Probiotics

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Maximum Eligible Age

13 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nutricia UK Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Brighton and Sussex University Hospital NHS Foundation Trust

Brighton, , United Kingdom

Site Status

University Hospitals Bristol NHS Foundation Trust

Bristol, , United Kingdom

Site Status

Ashford and St Peter's Hospital NHS Foundation Trust

Chertsey, , United Kingdom

Site Status

Royal Surrey County Hospital NHS Foundation Trust

Guildford, , United Kingdom

Site Status

Guy's and St Thomas' NHS Foundation Trust

London, , United Kingdom

Site Status

The Rotherham NHS Foundation Trust

Rotherham, , United Kingdom

Site Status

university Hospitals Southampton NHS Foundation Trust

Southampton, , United Kingdom

Site Status

West Hertfordshire NHS Foundation Trust

Watford, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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PEPSYN001 V6

Identifier Type: -

Identifier Source: org_study_id