Synbiotic Extensively Hydrolysed Feed Study

Nutricia

Status: Completed

Conditions: Cow Milk Allergy

Treatments: Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics

Study type: Interventional

Funder types: Industry

Identifiers

NCT03874104

PEPSYN001 V6

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: Under 13 months old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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35 participants in 1 patient group

Study product

Experimental group

Description:

Extensively Hydrolysed Formula containing Pre- and Probiotics

Treatment:

Dietary Supplement: Extensively Hydrolysed Formula containing Pre- & Probiotics