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NCT Number: NCT03874104

Synbiotic Extensively Hydrolysed Feed Study

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.

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Key information

Conditions

Cow Milk Allergy Food Hypersensitivity Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Milk Hypersensitivity

Age range

Up to 13 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brighton and Sussex University Hospital NHS Foundation Trust, Brighton, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Extensively Hydrolysed Formula containing Pre- & Probiotics

Dietary Supplement

Extensively Hydrolysed Formula containing Pre- and Probiotics

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nutricia UK Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2021
Study completion
2023
First posted
Mar 14, 2019
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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