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Trial registered on ANZCTR

Registration number

ACTRN12620000359932p

Ethics application status

Not yet submitted

Date submitted

28/01/2020

Date registered

13/03/2020

Date last updated

13/03/2020

Date data sharing statement initially provided

13/03/2020

Type of registration

Prospectively registered

Titles & IDs

Public title

Probiotics in the prevention of Gestational Diabetes Mellitus in women at increased risk: a prospective randomised controlled trial.

Scientific title

Probiotics in the prevention of Gestational Diabetes Mellitus in women at increased risk: a prospective randomised controlled trial.

Secondary ID [1]

Nil known

Universal Trial Number (UTN)

U1111-1247-2365

Trial acronym

Linked study record

Health condition

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

Gestational Diabetes Mellitus

Condition category

Condition code

Reproductive Health and Childbirth

Fetal medicine and complications of pregnancy

Metabolic and Endocrine

Diabetes

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Women will be recruited to the study at their booking-in appointment with the antenatal clinic (usually at 12 week's pregnancy). Participating women will be randomised to the intervention or control group. The intervention group will be given probiotic capsules to be taken once daily from enrolment until the results are received from their Glucose Tolerance Test, which is conducted at their 26-28 week antenatal care visit. The probiotic will contain a combination of strains lactobacillus rhamnosus and Bifidobacterium animalis ssp lactis and/or Bifidobacterium breve and Bifidobacterium longum as these are previously well researched strains specific for pregnancy. Lactobacillus rhamnosus and Bifidovacterium animalis ssp lactis have been shown to influence glucose metabolism through their immunoregulatory properties. The probiotic and placebo will be manufactured and supplied by Metagenetics (Aust) Pty Ltd. Given the fragile nature of the microbes in probiotics, women will be instructed to keep the capsules in a refrigerator and to avoid taking them within 10 minutes of consuming hot food or fluid. Adherence to the intervention will be monitored by counting the number of capsules in bottles returned by participants at their 26-28 week antenatal clinic visit. As per standard care, at their 26-28 antenatal clinic, all women will complete an Oral Glucose Tolerance Test. Completion of the test marks the end of their participation in the study.

Intervention code [1]

Prevention

Comparator / control treatment

The control group will be given placebo capsules containing (maize-derived maltodextrin) to be taken once daily from enrolment until the results are received from their Glucose Tolerance Test, which is conducted at their 26-28 week antenatal care visit.. The placebo will be identical in appearance and smell to the probiotic. The control group will also be instructed to keep the capsules in a refrigerator and to avoid taking them within 10 minutes of consuming hot food or fluid.

Control group

Placebo

Outcomes

Primary outcome [1]

The primary outcome is the incidence of gestational diabetes in the intervention group and the control group. This outcome will be assessed by the Oral Glucose Tolerance Test which is a routine test for pregnant women attending their 26-28 week antenatal care visit.

Timepoint [1]

Antenatal care appointment at week 26-28 of pregnancy.

Secondary outcome [1]

Change in weight from booking-in appointment with the antenatal clinic (approximately 12 weeks pregnancy) to routine antenatal care appointment at week 26-28 of pregnancy. Weight will be measured by antenatal clinic staff using clinic weighing scales.

Timepoint [1]

Week 26-28 of pregnancy.

Eligibility

Key inclusion criteria

All pregnant women >10 weeks gestation, in a singleton pregnancy at increased risk of gestational diabetes as per the Australasian Diabetes in Pregnancy Society (ADIPS) criteria will be eligible for the study:
• Previous GDM
• Maternal age 18 years to 40 years
• Family history of diabetes (1st degree relative with diabetes or a sister with GDM)
• BMI over 35kg/m2
• Previous macrosomia (baby birth weight over 4500g or over 90th centile)
• Polycystic ovarian syndrome

Minimum age

18 Years

Maximum age

40 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

• Not being able to read and understand English – unable to provide informed consent.
• Age <18 years
• Pregnancy >16 weeks gestation at recruitment
• Known pre-existing diabetes, impaired fasting glucose or impaired glucose tolerance
• GDM prior to recruitment as diagnosed by early pregnancy glucose testing – Early
pregnancy glucose testing routinely done for women at increased risk of GDM
• Medications likely to influence glucose metabolism – metformin, glucocorticoids,
immunosuppressants
• Medical conditions with altered glucose metabolism – Cushing/s syndrome, hepatic
cirrhosis
• Known major fetal anomaly on ultrasound
• Known current ingestion of probiotics via capsules or sachets
• Antibiotic use during the study period

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)

The allocation of participants to either the intervention group or the control group will be concealed to the persons recruiting participants. Computer-based randomisation will be centrally conducted with a study group (A or B) marked on the enrolment form. Only after participants have signed the study consent form, will an enrolment form be selected from a file containing all enrolment forms. Study recruiters will be instructed to remove the first enrolment form only. The unique study ID and study group on the form will match a bottle with the same ID of either the treatment or placebo. Study recruiters will not be aware which group (A or B) contains the probiotics.

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

A random group allocation table will be centrally generated using Stata 15 software.

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

The study will investigate both odds ratios and relative risks of GDM in the control and intervention groups. Unadjusted odds ratios and relative risks will be calculated. Bivariate analyses will investigate associations between baseline variables (e.g. demographic characteristics, maternal history, obstetric history and other risk factors parity) and development of GDM. A multivariable logistic regression model will be used to estimate the odds of women developing GDM in the intervention group vs. control group. An intention to treat analysis will be done with the primary analysis to account for poor compliance with trial participation.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/04/2020

Actual

Date of last participant enrolment

Anticipated

1/04/2021

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

340

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

TAS

Recruitment hospital [1]

North West Regional Hospital - Burnie

Recruitment hospital [2]

Mersey Community Hospital - Latrobe

Recruitment postcode(s) [1]

7320 - Burnie

Recruitment postcode(s) [2]

7307 - Latrobe

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

North West Regional Hospital

Address [1]

North West Regional Hospital
Hospitals' Campus, Brickport Road
Burnie
Tasmania 7320

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Anushika Samarage

Address

North West Regional Hospital
Hospitals' Campus, Brickport Road
Burnie
Tasmania 7320

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Not yet submitted

Ethics committee name [1]

University of Tasmania Tasmania Health & Medical Human Research Ethics Committee

Ethics committee address [1]

Health and Medical Research Ethics Committee
Office of Research Services
Private Bag 1
Hobart TAS 7001

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

27/03/2020

Approval date [1]

Ethics approval number [1]

Summary

Brief summary

The purpose of the study is to establish if probiotics taken in pregnancy can reduce the incidence of gestational diabetes (GDM) in women who are at increased risk of GDM. The study hypothesis is the administration of probiotics to pregnant women at risk of gestational diabetes from 12 weeks of gestation reduces the incidence of GDM diagnosed at 26-28 weeks gestation. The study is a prospective, double-blinded randomized controlled trial. Women attending public hospital antenatal services who are at increased risk of developing GDM will be invited to participate. Participants will be randomly allocated to either the control group receiving a placebo or the intervention group receiving probiotics daily from booking in appointment (usually approx. 12 weeks gestation) until the Oral Glucose Tolerance Test (routinely done at 26-28 weeks gestation). Women. The primary outcome is incidence of GDM in the control and intervention groups..

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Anushika Samarage

Address

North West Regional Hospital
Hospitals' Campus, Brickport Road
Burnie
Tasmania
7320

Country

Australia

Phone

+61 0477427426

Fax

[email protected]

Contact person for public queries

Name

Anushika Samarage

Address

North West Regional Hospital
Hospitals' Campus, Brickport Road
Burnie
Tasmania
7320

Country

Australia

Phone

+61 0477427426

Fax

[email protected]

Contact person for scientific queries

Name

Anushika Samarage

Address

North West Regional Hospital
Hospitals' Campus, Brickport Road
Burnie
Tasmania
7320

Country

Australia

Phone

+61 0477427426

Fax

[email protected]

Data sharing statement

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

Yes

What data in particular will be shared?

We currently have no plans to make individual participant data available, however if we receive a request we will seek ethics committee approval prior to sharing data. We would be willing to share de-identified individual participant data underlying published results.

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

Immediately following publication and for 3 years following main results publication.

Available to whom?

The data would be provided on a case-by-case basis at the discretion of the Principal Investigator.

Available for what types of analyses?

The data would be provided only to achieve the aims in the approved proposal.

How or where can data be obtained?

Access subject to approvals by Principal Investigator: Dr Anushika Samarage, [email protected]

What supporting documents are/will be available?

Doc. No.	Type	Email
6589	Study protocol	[email protected]
6590	Informed consent form	[email protected]
6591	Ethical approval	[email protected]

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.

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