ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000968774

Ethics application status

Approved

Date submitted

6/07/2022

Date registered

8/07/2022

Date last updated

17/03/2024

Date data sharing statement initially provided

8/07/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

The BLOOM Study - can brewer's yeast or beta-glucan increase breast milk supply following preterm birth?

Scientific title

The BLOOM Study - can Brewer’s yeast or beta-gLucan increase mOther’s Own Milk supply following preterm birth?

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1278-8827

Trial acronym

BLOOM

Linked study record

Health condition

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

Lactation insufficiency

Preterm birth

Condition category

Condition code

Reproductive Health and Childbirth

Breast feeding

Reproductive Health and Childbirth

Complications of newborn

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Arm 1 - Brewer's Yeast, three 280 mg capsules administered orally twice a day (morning and evening), for a total daily dose of 1680 mg/day, intervention duration of seven days.

Arm 2 - Beta-glucan, one 250 mg capsule administered orally once per day (morning), administered with two placebo capsules in the morning and three placebo capsules in the evening, intervention duration of seven days.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

Placebo - capsules containing microcrystalline cellulose, three capsules administered in the morning and three in the evening, orally, for seven days.

Control group

Placebo

Outcomes

Primary outcome [1]

Daily expressed breast milk volume. Identified from expressed volume recorded over a 24-hour period using a breast milk diary completed by mothers.

Timepoint [1]

Day 7 of the intervention

Secondary outcome [1]

Maternal adverse events will be assessed using a study-specific questionnaire with reference to known/possible adverse events including diarrhoea, nausea, vomiting, abdominal pain, cramping and rash.

Timepoint [1]

From first study dose up to day 7 of intervention.

Secondary outcome [2]

Use and volume of supplementation to mother's own breast milk, such as formula or donor breast milk, extracted from infant medical records

Timepoint [2]

Day 7 of intervention and at infant discharge from hospital or infant term corrected age (if this occurs before discharge)

Secondary outcome [3]

Proportion breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle or nasogastric tube feeding it to the infant), collected through maternal self-report and case note review.

Timepoint [3]

At infant discharge from hospital or infant term corrected age (if this occurs before discharge)

Secondary outcome [4]

Duration of breastfeeding or breast milk feeding (defined as the process of feeding a mother's breast milk to her infant, either directly from the breast or by expressing the milk from the breast and bottle or nasogastric tube feeding it to the infant), collected through maternal self-report and case note review.

Timepoint [4]

Until infant discharge from hospital or infant term corrected age (if this occurs before discharge)

Secondary outcome [5]

Mean daily breast milk volume using a breast milk diary completed by the mother

Timepoint [5]

From day 0 of intervention to postnatal day 21

Secondary outcome [6]

Total breast milk volume assessed using a breast milk diary completed by the mother

Timepoint [6]

Day 0 of intervention to postnatal day 21

Secondary outcome [7]

Maternal serum prolactin concentration

Timepoint [7]

Day 7 of intervention

Secondary outcome [8]

Breast milk composition assessed by measuring protein, fat, and carbohydrate concentration

Timepoint [8]

Day 7 of intervention

Secondary outcome [9]

Treatment adherence as measured by participant diary

Timepoint [9]

Day 7 of intervention

Eligibility

Key inclusion criteria

- Infant born <34 weeks’ gestation (i.e. up to 33+6)
- Intention to provide breast milk
- Between 0 to 72 hours of birth
- Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments
- Adequate English language skills
- Signed, written informed consent.

Minimum age

18 Years

Maximum age

No limit

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

- Contraindication to breastfeeding
- Higher order pregnancies (triplet or more)

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)

Central randomisation by computer

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

Allocation will follow a computer generated randomisation schedule using randomly permuted blocks. Randomisation stratified by study centre.

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

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

A sample of 99 women (33 per arm) yields 90% power, 0.025 alpha to show a difference in the mean daily breast milk volume of 150 mL/day (200 mL/day standard deviation) between each of the intervention arms and control, allowing for 10% loss to follow-up. This includes adjustment for a 0.6 correlation between breast milk volume at study entry and breast milk volume on day 7.

The primary analysis will be performed according to the treatment group to which participants were randomised (intention-to-treat principle). A secondary per-protocol analysis will also be performed for each of the primary and secondary outcomes.
The primary outcome of daily breast milk volume on day 7 will be compared between treatment groups using a linear regression. The results will be expressed as a difference in means with a 95% confidence interval and two-sided p-value. Adjustment will be made for baseline breast milk volume and the randomization strata (study centre). A p-value of less than 0.05 will be considered to indicate statistical significance. Analysis of secondary outcomes will use log-binomial regression models for binary outcomes and linear regression models for continuous outcomes with adjustment for stratification variables and other pre-specified prognostic baseline variables. Results will be presented as relative risks and differences in means respectively, along with 95% confidence intervals. Missing data will be addressed using multiple imputation. Sensitivity analyses will also be performed using the original unimputed data.

Planned sub-group analyses of the primary and secondary breastfeeding outcomes include:
(i) Plurality (Singleton vs. twins)
(ii) Parity (Primiparous vs. multiparous)
(iii) Infant gestation at birth (23+0–29+6 vs. 30+0–31+6 vs 32+0-33+6 weeks’ gestation)
(iv) Maternal body mass index (Underweight/Normal weight vs. Overweight/Obese)
Effect modification by each of these factors will be assessed separately by including interaction effects with treatment group in the statistical models.

Recruitment

Recruitment status

Recruiting

Date of first participant enrolment

Anticipated

1/08/2022

Actual

19/08/2022

Date of last participant enrolment

Anticipated

30/04/2024

Actual

Date of last data collection

Anticipated

31/08/2024

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

Womens and Childrens Hospital - North Adelaide

Recruitment hospital [2]

Flinders Medical Centre - Bedford Park

Recruitment hospital [3]

The Royal Women's Hospital - Parkville

Recruitment postcode(s) [1]

5006 - North Adelaide

Recruitment postcode(s) [2]

5042 - Bedford Park

Recruitment postcode(s) [3]

3052 - Parkville

Funding & Sponsors

Funding source category [1]

University

Name [1]

Flinders University

Address [1]

Sturt Road, Bedford Park, South Australia, 5042

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Leiber GmbH

Address [2]

Hafenstraße 24, 49565 Bramsche

Country [2]

Germany

Funding source category [3]

Charities/Societies/Foundations

Name [3]

Channel 7 Children's Research Foundation

Address [3]

341 Port Rd, Hindmarsh SA 5007

Country [3]

Australia

Primary sponsor type

Other Collaborative groups

Name

South Australian Health and Medical Research Institute

Address

North Terrace
Adelaide 5000
South Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Women's and Children's Health Network Human Research Ethics Committee

Ethics committee address [1]

Women's and Children's Hospital 72 King William Road North AdelaideSA 5006

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/01/2022

Approval date [1]

31/03/2022

Ethics approval number [1]

HREC/22/WCHN/00001

Summary

Brief summary

Mothers of preterm infants often struggle to produce enough breast milk to meet the daily feed requirements of their infants, especially in the longer-term. This randomized multi-centre double-blind parallel controlled trial will evaluate the efficacy and safety of two commonly used galactagogues, Brewer’s yeast and beta-glucan, compared with placebo in improving maternal breast milk supply following preterm birth.

Eligible women will be randomised to receive Brewer's yeast (1680 mg/day), Beta-glucan (250 mg/day) or placebo for 7 days, commencing within 72 hours of birth. The primary outcome will be assessed at day 7 following treatment initiation. 

All participants will undertake regular study assessments including at baseline (study enrolment), day 7 of treatment, postnatal day 21 and at infant discharge to home or term corrected (whichever comes first). Women will regularly undertake questionnaires evaluating demographics and lifestyle, breast health, milk expression, postnatal health, mental health and wellbeing, and infant feeding practices. Women will also undergo anthropometric assessment, and a breast milk, blood, urine, stool and buccal cell swab sample.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

A/Prof Luke Grzeskowiak

Address

College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 423 554 614

Fax

luke.grzeskowiak@flinders.edu.au

Contact person for public queries

Name

Luke Grzeskowiak

Address

College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 423 554 614

Fax

luke.grzeskowiak@flinders.edu.au

Contact person for scientific queries

Name

Luke Grzeskowiak

Address

College of Medicine and Public Health Flinders University GPO Box 2100, Adelaide 5001, South Australia

Country

Australia

Phone

+61 423 554 614

Fax

luke.grzeskowiak@flinders.edu.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?

Baseline Characteristics: including demographics, age and study-specific measures for all participants, after de-identification.
Outcome data: all of the individual participant data collected during the trial, after de-identification

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

Beginning 3 months following main results publication; no end date determined

Available to whom?

To researchers who provide a methodologically sound proposal, and on a case-by-case basis at the discretion of Primary Sponsor

Available for what types of analyses?

For IPD meta-analyses.

How or where can data be obtained?

Access subject to approvals by Principal Investigator (luke.grzeskowiak@flinders.edu.au).

What supporting documents are/will be available?

Doc. No.	Type	Email
16267	Study protocol	luke.grzeskowiak@flinders.edu.au
16268	Informed consent form	luke.grzeskowiak@flinders.edu.au
16269	Ethical approval	luke.grzeskowiak@flinders.edu.au

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

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No additional documents have been identified.

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