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Synbiotic Extensively Hydrolysed Feed Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03874104
Recruitment Status : Recruiting
First Posted : March 14, 2019
Last Update Posted : July 8, 2019
Information provided by (Responsible Party):
Nutricia UK Ltd

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.

Condition or disease Intervention/treatment Phase
Cow Milk Allergy Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : August 22, 2018
Estimated Primary Completion Date : June 1, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

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

Primary Outcome Measures :
  1. Change in gastrointestinal tolerance from baseline to intervention day 28: questionnaire [ Time Frame: 31 days ]
    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 :
  1. Compliance [ Time Frame: 31 days ]
    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.

  2. Parent-reported Atopic Symptoms [ Time Frame: 31 days ]
    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/

  3. Food Allergy QOL - Parental burden questionnaire [ Time Frame: 31 days ]
    Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire

  4. Formula acceptability: Likert-style questionnaire [ Time Frame: 31 days ]
    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

  5. Nutrient intake [ Time Frame: 31 days ]
    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.

  6. Atopic dermatitis severity [ Time Frame: 31 days ]
    Measured via Patient Orientated SCORing Atopic Dermatitis (PO-SCORAD) tool at Baseline, Intervention Day 7 and the final dat of the study

  7. Change in weight [ Time Frame: 31 days ]
    Weight will be measured at the start and end of the study in kg

  8. Safety (Adverse Events) [ Time Frame: 31 days ]
    Adverse events captured throughout entire study

  9. Change in length (cm) [ Time Frame: 31 days ]
    Length will be measured at the start and end of the study

  10. Change in head circumference (cm) [ Time Frame: 31 days ]
    Head circumference will be measured at the start and end of the study

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   up to 13 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03874104

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Contact: Robert Browne 07507033515

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

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Responsible Party: Nutricia UK Ltd Identifier: NCT03874104    
Other Study ID Numbers: PEPSYN001 V6
First Posted: March 14, 2019    Key Record Dates
Last Update Posted: July 8, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Milk Hypersensitivity
Immune System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate