RecruitingACTRN12624000670572

Investigating the management of allergy with amino acid-based formula and synbiotics in Australian infants with cow’s milk allergy

Investigating the efficacy of the management of allergy with amino acid-based formula and synbiotics in Australian infants with cow’s milk allergy

Sponsor

Western Sydney University

Enrollment

89 participants

Start Date

Feb 4, 2025

Study Type

Interventional

Conditions

Cow's Milk Allergy

Summary

This study will follow infants diagnosed with cow's milk allergy as they are prescribed a commercially available amino acid formla. The formula contains a combination of prebiotics (short chain galactooligosaccharides and long-chain fructo-oligosaccharides), probiotics (Bifidobacterium breve M-16V) and human milk oligosaccharide (2'Flucosyllactose). The aim is to generate local real-world evdience on the effectiveness of the formula based on parent-reported and investigator-reported outcomes questionnaires and infant microbiota profile. The hypothesis is that the formula would improve overall allergy symptoms.

Eligibility

Sex: Both males and femalesMin Age: 0 MonthssMax Age: 6 Monthss

Plain Language Summary

Simplified for easier understanding

Cow's milk allergy (CMA) is one of the most common food allergies in infants, causing symptoms like rashes, vomiting, diarrhoea, and irritability. When breastfeeding is not possible, infants with CMA need a special formula that their body can tolerate. This study from Western Sydney University is following infants who are prescribed a specific amino acid formula that also contains a combination of prebiotics, probiotics, and a human milk sugar called 2'Fucosyllactose. The aim is to gather real-world Australian evidence on how well this formula controls allergy symptoms, and to understand how it affects the baby's gut microbiome (the community of bacteria in the gut). Parents will complete questionnaires about their baby's symptoms, and microbiota samples will be collected at study visits. Your infant may be eligible if they are under 6 months old, have recently been diagnosed (or are highly suspected) to have cow's milk allergy, are already formula-fed or you have decided to start formula feeding. Infants with purely functional gut symptoms (without suspected allergy) or who have contraindications to synbiotics — such as prematurity, short bowel, or cancer treatment — are not eligible.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

The study aims to evaluate the clinical effectiveness of an extensively hydrolysed amino acid formula with added synbiotics. The formula is a commercially available Aptamil PEPTI SYNEO 2’FL, extensively hydrolysed amino acid formula (suitable 0 – 12 months) with added short chain galactooligosaccharides and long-chain fructo-oligosaccharides (scGOS/lcFOS), Bifidobacterium breve M-16V (SYNEO), and 2’-Flucosyllactose (2’FL). Formula will be prescribed by the clinical investigators according to their judgement and professional responsibility. The study aim would be achieved through obtaining evidence in a real-world setting, where data will be generated during routine patient care. In addition, the patient’s parents will be asked to fill in a set of questionnaires and to collect stool samples (and stool photographs) from their infant. The formula dosage and duration will be prescribed by the paediatric gastroenterologist for each individual based on the physician's clinical judgement and professional responsibility. Adherence would be monitored through the parent's self-reporting - the "Formula Intake" questinonnaire will capture the frequency and volume of formula fed as well as other intake (e.g. breastmilk) on a daily bases during the study.

Locations(1)

NSW,SA, Australia

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