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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624000670572

Enrollment

Registered

2024-05-27

Start date

2025-02-04

Completion date

2026-07-16

Last updated

2025-10-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief 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.

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.

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

0 to 6 Months

Healthy volunteers

Inclusion criteria

1. Infants less than 6 months of age at study entry; 2. With recently confirmed (or highly suspected) CMA, based on physician judgement; 3. Already formula-fed or parents already made the decision to start with formula feeding; 4. Written informed consent provided by parents/guardians, according to local law.

Exclusion criteria

1. Infants with functional gastrointestinal symptoms where atopy and food allergy is NOT suspected. 2. Contraindications to use synbiotics (e.g. prematurity, short bowel, parenteral nutrition, post pyloric feeding, central venous catheter, patients undergoing oncology treatment, graft-versus-host-disease, GVHD); 3. Any other criteria, assessed by the physician, to contraindicate the use of an amino acid-based formula.

Outcome results