ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12615001075572

Ethics application status

Approved

Date submitted

18/09/2015

Date registered

13/10/2015

Date last updated

5/04/2024

Date data sharing statement initially provided

11/03/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Investigating the effect of maternal prebiotic fibre supplementation during pregnancy and breastfeeding on the prevention of early childhood allergies.

Scientific title

A randomised, double-blind, placebo-controlled trial to investigate the effects of maternal dietary prebiotic fibre supplementation, from early pregnancy to 6 months lactation, on infant outcomes of immune function and eczema diagnosis.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

SYMBA Study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Allergic Disease

Condition category

Condition code

Inflammatory and Immune System

Allergies

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

2 scoops of study powder containing 9g prebiotics (scGOS/IcFOS 9:1 ratio) will be mixed with food or beverage and consumed orally once daily by the participating pregnant women from study entry (18-20 weeks gestation) until 6 months of lactation. Compliance with the intervention will be assessed by questions asked at regular phone calls and appointment visits during the intervention period. The participating women will also be asked to return any unused study powder tins for reweighing as another measure of compliance at the end of the intervention period.

Intervention code [1]

Prevention

Comparator / control treatment

2 scoops of study powder containing 8g of maltodextrin powder will be mixed with food or beverage and consumed orally once daily by the participating pregnant women from study entry (18-20 weeks gestation) until 6 months of lactation. Compliance with the intervention will be assessed by questions asked at regular phone calls and appointment visits during the intervention period. The participating women will also be asked to return any unused study powder tins for reweighing as another measure of compliance at the end of the intervention period.

Control group

Placebo

Outcomes

Primary outcome [1]

Infant medically diagnosed eczema by 1 year of age. Infant medically diagnosed eczema is defined by typical eczema skin lesions clinically observed by a medical practitioner. Parents report to trial staff if their infant has been diagnosed with eczema by a medical doctor.

Timepoint [1]

1 year of age

Secondary outcome [1]

In this composite secondary outcome, the development of allergic disease (eczema and/or food allergy) in the infant, will be determined by completion of interview-administered questions and the infant will be examined for signs of allergic disease.

Timepoint [1]

At 3, 6 and 12 months of age of the infant.

Secondary outcome [2]

In this composite secondary outcome, the child's sensitisation to food and/or aeroallergens will be assessed by allergy skin prick testing (SPT) with histamine and control solutions in accordance with standard clinical methods as outlined in the 2009 ASCIA Skin Prick Testing for the Diagnosis of Allergic Disease: A manual for practitioners.

Timepoint [2]

At 12 months of age of the infant.

Secondary outcome [3]

Parent reported medically diagnosed asthma.

Timepoint [3]

Secondary outcome [4]

Parent reported medically diagnosed asthma.

Timepoint [4]

Assessed by parent questionnaire at 3 and 5 years of age

Secondary outcome [5]

Parent reported medically diagnosed eczema

Timepoint [5]

Assessed by parent questionnaire at 3 and 5 years of age

Secondary outcome [6]

Parent reported medically diagnosed eczema

Timepoint [6]

Assessed by parent questionnaires at 3 and 5 years of age.

Secondary outcome [7]

Parent reported symptoms of allergic rhinitis (hay fever).

Timepoint [7]

Assessed by parent questionnaires at 3 and 5 years of age.

Secondary outcome [8]

Parent reported symptoms of allergic rhinitis (hay fever).

Timepoint [8]

Assessed by parent questionnaire at 3 and 5 years of age.

Eligibility

Key inclusion criteria

Pregnant women less than 21 weeks of gestation, whose infants have a first-degree relative (mother, father or sibling) with a history of medically diagnosed allergic disease (asthma, allergic rhinitis, eczema and/or food allergy). Eligibility is not dependent on intent to breastfeed for a given length of time.

Minimum age

18 Years

Maximum age

50 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

Maternal smoking during pregnancy.
Women already regularly consuming prebiotic supplement (more than twice a week).
Current maternal diagnosis of lactose intolerance or cows milk allergy or other significant chronic gastrointestinal condition.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Written informed consent will be obtained before participating in an enrolment appointment. Each participating pregnant woman will be assigned a unique study number and randomly allocated (computer generated) into one of two intervention groups.
The allocation will be concealed be central randomisation using a computer system.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

The randomisation schedule will be computer-generated (varying size of permuted blocks), and stratified by maternal allergy status and body mass index (BMI). The randomisation schedule will be produced by an independent party.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

We can detect differences in aspects of immune function in studies of this size or smaller, including differences in cytokine detection in our previous intervention studies using probiotics in pregnancy. Although no specific sample size calculations were done for the composite primary outcome for this trial, the subgroup of 120 (60 per group) infant blood samples at 6 months of age that will be selected for immunological studies will be sufficient to detect biologically relevant differences in proposed immune outcomes. This is based on our extensive experience with similar populations.
All analyses will be on an intention-to-treat basis.
For the biological analysis: continuous variables (e.g. cytokines) will be compared between groups with linear regression models (transformation of the outcome variable will be employed as required to meet the assumptions of the linear regression model) to allow for adjustment of confounders. Binary variables will be compared using logistic regression to allow for adjustment of relevant prognostic baseline variables and confounding post-randomisation interactions.

For the clinical analysis, the proportion of children with diagnosed allergic disease at 12 months of age will be compared between treatment groups using an identity binomial generalized linear model, adjusting for the pre-specified prognostic stratification variables. Differences in secondary clinical outcomes will be examined in the same way.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

27/05/2016

Actual

29/06/2016

Date of last participant enrolment

Anticipated

Actual

18/11/2021

Date of last data collection

Anticipated

30/06/2027

Actual

Sample size

Target

652

Accrual to date

Final

652

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Joondalup Health Campus - Joondalup

Recruitment postcode(s) [1]

6027 - Joondalup

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Telethon-Perth Children’s Hospital Research Fund Department of Health of Western Australia

Address [1]

Department of Health of Western Australia
PO Box 8172
Perth Business Centre
WA 6849

Country [1]

Australia

Funding source category [2]

Government body

Name [2]

National Health and Medical Research Council

Address [2]

GPO Box 9848 Canberra ACT 2601

Country [2]

Australia

Funding source category [3]

Government body

Name [3]

Western Australia Child Health Research Fund Grant

Address [3]

Department of Health of Western Australia PO Box 8172 Perth Business Centre WA 6849

Country [3]

Australia

Primary sponsor type

Other

Name

Telethon Kids Institute

Address

100 Roberts Road
Subiaco, 6008
Western Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Joondalup Health Campus Human Research Ethics Committee

Ethics committee address [1]

Grand Blvd & Shenton Avenue 
Joondalup, 6026
WA

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

05/11/2014

Approval date [1]

02/02/2016

Ethics approval number [1]

1541r

Summary

Brief summary

This project will recruit pregnant women to receive either a prebiotic supplement or a placebo supplement. They will be asked to take the supplement from 18-20 weeks gestation until their baby is 6 months of age. We will then examine whether supplementing the mother’s diet during pregnancy and breastfeeding with the prebiotic powder will reduce the development of allergies in her child. Both study groups will include children deemed to be at high risk of allergic disease (based on family allergy history).

Trial website

Trial related presentations / publications

Debra J. Palmer, Jeffrey Keelan, Johan Garssen, Karen Simmer, Maria C. Jenmalm, Ravisha Srinivasjois, Desiree Silva, Susan L. Prescott. Study protocol for a randomised controlled trial investigating the effects of maternal prebiotic fibre dietary supplementation from mid-pregnancy to six months’ post-partum on child allergic disease outcomes. Nutrients 2022;14(13):2753. https://doi.org/10.3390/nu14132753

Public notes

Contacts

Principal investigator

Name

Prof Susan Prescott

Address

Telethon Kids Institute
100 Roberts Road
Subiaco WA 6008

Country

Australia

Phone

+61 8 9489 7714

Fax

susan.prescott@telethonkids.org.au

Contact person for public queries

Name

Debra Palmer

Address

Childhood Allergy and Immunology Research, Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 8 6319 1750

Fax

debbie.palmer@telethonkids.org.au

Contact person for scientific queries

Name

Debra Palmer

Address

Childhood Allergy and Immunology Research, Level 7, Telethon Kids Institute, Perth Children's Hospital, 15 Hospital Ave, Nedlands WA 6009

Country

Australia

Phone

+61 8 6319 1750

Fax

debbie.palmer@telethonkids.org.au

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

After de-identification, individual participant data underlying published results only.

When will data be available (start and end dates)?

Beginning 6 months and ending 5 years following main results publication.

Available to whom?

Case-by-case basis at the discretion of CIs Susan Prescott and Debra Palmer

Available for what types of analyses?

For IPD meta-analyses

How or where can data be obtained?

Access subject to approvals by CIs Susan Prescott and Debra Palmer

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
Study protocol	Debra J. Palmer, Jeffrey Keelan, Johan Garssen, Karen Simmer, Maria C. Jenmalm, Ravisha Srinivasjois, Desiree Silva, Susan L. Prescott. Study protocol for a randomised controlled trial investigating the effects of maternal prebiotic fibre dietary supplementation from mid-pregnancy to six months’ post-partum on child allergic disease outcomes. Nutrients 2022;14(13):2753. https://doi.org/10.3390/nu14132753
Statistical analysis plan					369064-(Uploaded-16-07-2023-13-12-27)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Maternal Fiber Dietary Intakes during Pregnancy and Infant Allergic Disease	2019	https://doi.org/10.3390/nu11081767
Embase	Study Protocol for a Randomised Controlled Trial Investigating the Effects of Maternal Prebiotic Fibre Dietary Supplementation from Mid-Pregnancy to Six Months' Post-Partum on Child Allergic Disease Outcomes.	2022	https://dx.doi.org/10.3390/nu14132753

N.B. These documents automatically identified may not have been verified by the study sponsor.

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