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Trial registered on ANZCTR


Registration number
ACTRN12624000670572p
Ethics application status
Submitted, not yet approved
Date submitted
6/05/2024
Date registered
27/05/2024
Date last updated
27/05/2024
Date data sharing statement initially provided
27/05/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the management of allergy with amino acid-based formula and synbiotics in Australian infants with cow’s milk allergy
Scientific title
Investigating the efficacy of the management of allergy with amino acid-based formula and synbiotics in Australian infants with cow’s milk allergy
Secondary ID [1] 312090 0
NA006
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cow's Milk Allergy 333719 0
Condition category
Condition code
Inflammatory and Immune System 330401 330401 0 0
Allergies

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328531 0
Treatment: Other
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 338155 0
Physician reported changes in allergy symptoms (skin/digestive/respiratory/general) compared to baseline (worsened/remain the same/improved/completely resolved) in infants with cow’s milk allergy (CMA). This will be assessed as a composite outcome.
Timepoint [1] 338155 0
Baseline and at end-of-study (4 weeks post-enrollment)
Secondary outcome [1] 434746 0
Cow's Milk Allergy Symptoms
Timepoint [1] 434746 0
At baseline and end of study (4 weeks post-enrollment)
Secondary outcome [2] 434997 0
Changes in allergy symptoms (skin / digestive / respiratory / general) compared to baseline (worsened / remained the same / improved / completely resolved). This will be assessed as a composite outcome.
Timepoint [2] 434997 0
At baseline and end of study (4 weeks post-enrollment)
Secondary outcome [3] 434998 0
Anthropometrics (infant weight and length)
Timepoint [3] 434998 0
At baseline and end of study (4 weeks post-enrollment)
Secondary outcome [4] 434999 0
Parent-perceived gastrointestinal symptoms
Timepoint [4] 434999 0
At baseline and end of study (4 weeks post-enrollment)
Secondary outcome [5] 435000 0
Severity of atopic dermatitis
Timepoint [5] 435000 0
At baseline and end of study (4 weeks post-enrollment)
Secondary outcome [6] 435001 0
Allergy and gastrointestinal symptoms. This will be assessed as a composite outcome.
Timepoint [6] 435001 0
Daily for first 14 days, then weekly until the end of study (4 weeks post-enrollment)
Secondary outcome [7] 435002 0
Severity of atopic dermatitis
Timepoint [7] 435002 0
Completed weekly during the 4-week study period (4 times in total)
Secondary outcome [8] 435003 0
Quality of life - Parental burden
Timepoint [8] 435003 0
At baseline and end of study (4 weeks post enrollment)
Secondary outcome [9] 435004 0
Product acceptability and appreciation. This will be assessed as a composite outcome.
Timepoint [9] 435004 0
At end of study (4 weeks post-enrollment)
Secondary outcome [10] 435005 0
Product intake
Timepoint [10] 435005 0
Daily for the duration of the study (4 weeks post-enrollment)
Secondary outcome [11] 435007 0
Stool characteristics and microbiome. This will be assessed as a composite outcome.
Timepoint [11] 435007 0
At baseline and end of study (4 weeks post-enrollment)

Eligibility
Key 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.
Minimum age
0 Months
Maximum age
6 Months
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
17/06/2024
Actual
Date of last participant enrolment
Anticipated
18/06/2025
Actual
Date of last data collection
Anticipated
16/07/2025
Actual
Sample size
Target
89
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA

Funding & Sponsors
Funding source category [1] 316447 0
Commercial sector/Industry
Name [1] 316447 0
Nutricia Australia Pty Limited
Country [1] 316447 0
Australia
Primary sponsor type
University
Name
Western Sydney University
Address
Country
Australia
Secondary sponsor category [1] 318616 0
None
Name [1] 318616 0
Address [1] 318616 0
Country [1] 318616 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315238 0
University of Western Sydney Human Research Ethics Committee
Ethics committee address [1] 315238 0
https://www.westernsydney.edu.au/research/research_ethics_and_integrity/human_ethics/apply_for_human_research_ethics_review
Ethics committee country [1] 315238 0
Australia
Date submitted for ethics approval [1] 315238 0
06/05/2024
Approval date [1] 315238 0
Ethics approval number [1] 315238 0

Summary
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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134094 0
Dr Jerry Zhou
Address 134094 0
School of Medicine, Western Sydney University, Building 30, Goldsmith Av, Campbelltown NSW 2560
Country 134094 0
Australia
Phone 134094 0
+61 246203865
Fax 134094 0
Email 134094 0
[email protected]
Contact person for public queries
Name 134095 0
Jerry Zhou
Address 134095 0
School of Medicine, Western Sydney University, Building 30, Goldsmith Av, Campbelltown NSW 2560
Country 134095 0
Australia
Phone 134095 0
+61 246203865
Fax 134095 0
Email 134095 0
[email protected]
Contact person for scientific queries
Name 134096 0
Jerry Zhou
Address 134096 0
School of Medicine, Western Sydney University, Building 30, Goldsmith Av, Campbelltown NSW 2560
Country 134096 0
Australia
Phone 134096 0
+61 246203865
Fax 134096 0
Email 134096 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
The study is part of the global SMASH study initiated by Nutricia Research, Danone Asia Pacific Holding, and Nutricia Australia. Although the results of this study is expected to be presented at public conferences and publications, these entities may choose to limit publication of commercially sensitive, or embargo certain data pending commercial disclosure review.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.