Synbiotic Extensively Hydrolysed Feed Study

Cow Milk Allergy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03874104
• Other study ID #: PEPSYN001 V6
• Status: Completed
• Phase: N/A
• Start date: August 22, 2018
• Est. completion date: July 31, 2023

Study information

• Verified date: November 2023
• Source: Nutricia UK Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 31, 2023
• Est. primary completion date: December 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 13 Months

Eligibility

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

Related Conditions & MeSH terms

• Cow Milk Allergy
• Hypersensitivity
• Milk Hypersensitivity

Intervention

Dietary Supplement:
• Extensively Hydrolysed Formula containing Pre- & Probiotics
Extensively Hydrolysed Formula containing Pre- and Probiotics

Locations

Country	Name	City	State
United Kingdom	Brighton and Sussex University Hospital NHS Foundation Trust	Brighton
United Kingdom	University Hospitals Bristol NHS Foundation Trust	Bristol
United Kingdom	Ashford and St Peter's Hospital NHS Foundation Trust	Chertsey
United Kingdom	Royal Surrey County Hospital NHS Foundation Trust	Guildford
United Kingdom	Guy's and St Thomas' NHS Foundation Trust	London
United Kingdom	The Rotherham NHS Foundation Trust	Rotherham
United Kingdom	university Hospitals Southampton NHS Foundation Trust	Southampton
United Kingdom	West Hertfordshire NHS Foundation Trust	Watford

Sponsors (1)

Lead Sponsor	Collaborator
Nutricia UK Ltd

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	31 days
Secondary	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/	31 days
Secondary	Food Allergy QOL - Parental burden questionnaire	Measured at baseline and at the end of study via a Food Allergy QOL - Parental Burden Questionnaire	31 days
Secondary	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	31 days
Secondary	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.	31 days
Secondary	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	31 days
Secondary	Change in weight	Weight will be measured at the start and end of the study in kg	31 days
Secondary	Safety (Adverse Events)	Adverse events captured throughout entire study	31 days
Secondary	Change in length (cm)	Length will be measured at the start and end of the study	31 days
Secondary	Change in head circumference (cm)	Head circumference will be measured at the start and end of the study	31 days