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Trial registered on ANZCTR
Registration number
ACTRN12624000930583p
Ethics application status
Submitted, not yet approved
Date submitted
12/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
Evaluation of Faecal microbiota following PRobiotics in Infants of Mothers with Diabetes (PRIMD) trial: a double-blind placebo-controlled pilot randomized trial
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Scientific title
Evaluation of Faecal microbiota following PRobiotics in Infants of Mothers with Diabetes (PRIMD) trial: a double-blind placebo-controlled pilot randomized trial
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Secondary ID [1]
312525
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nil known
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Universal Trial Number (UTN)
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Trial acronym
PRIMD
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Infants of mothers with gestational diabetes
334397
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Condition category
Condition code
Oral and Gastrointestinal
331038
331038
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Metabolic and Endocrine
331090
331090
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0
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Diabetes
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Reproductive Health and Childbirth
331091
331091
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0
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Complications of newborn
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
3 billion Colony Forming Units (CFU)/ day of a combination of Bifidobacteria probiotic (1 billion CFU each of B. breve M-16V, B. longum subsp. infantis M-63 and B. longum subsp. longum BB536) given orally daily starting with first feed after birth and continued for a period of 4 months (till weaning started). Adherence to intervention will be monitored by clinical trials pharmacy by checking sachets consumed and frequency of picking up repeat prescription of the probiotic/ placebo
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Intervention code [1]
329041
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Treatment: Other
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Comparator / control treatment
Control group will receive placebo (dextrin) with similar weight and packaging as the probiotic
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Faecal microbiota at birth or first week of life and at 4 months of age after supplementation
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Assessment method [1]
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16S ribosomal RNA gene sequencing and next generation sequencing
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Timepoint [1]
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timepoint 1 (T1: at birth or in first week of life) and timepoint 2 (T2: after 4 months of supplementation before starting weaning)
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Secondary outcome [1]
437506
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Faecal short chain fatty acids (butyrate, acetate, propionate) as one of composite secondary outcomes
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Assessment method [1]
437506
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modified gas chromatography-mass spectrometry
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Timepoint [1]
437506
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T1 (timepoint 1: within first week of birth) and T2 (timepoint 2: after 4 months of intervention with placebo or probiotic before starting weaning)
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Secondary outcome [2]
437507
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Growth parameters (weight) in kg
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Assessment method [2]
437507
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routine anthropometry using weighing machine
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Timepoint [2]
437507
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At birth, 4, 12 and 24-months of age
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Secondary outcome [3]
437508
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Developmental data
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Assessment method [3]
437508
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completion of ages and stages questionnaire; 3rd edition (ASQ-3) by parents
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Timepoint [3]
437508
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4,12 and 24-months of age
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Secondary outcome [4]
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Growth (length) in cms
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Assessment method [4]
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Routine anthropometry: using stadiometer or infantometer
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Timepoint [4]
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at 4,12 and 24-months of age
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Secondary outcome [5]
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Growth (head circumference) in cms
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Assessment method [5]
437711
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routine anthropometric measurement using tape measure
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Timepoint [5]
437711
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at 4, 12 and 24-months of age
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Secondary outcome [6]
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Developmental data specific for social-emotional development
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Assessment method [6]
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completion of validated questionnaire Ages-and-stages-questionnaire-social emotional; 2nd edition (ASQ-SE2) by parents
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Timepoint [6]
437712
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at 4,12 and 24 months of age
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Eligibility
Key inclusion criteria
gestation>35 weeks at birth
Infant of mother with gestational diabetes mellitus
predominantly breast feeding and intending to breast feed in future
resident of Perth metropolitan area
informed parental consent
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Minimum age
1
Days
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Maximum age
120
Days
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Resident outside Perth metropolitan area
presence of maternal chorioamnionitis or prolonged rupture of membranes (>18 hours)
babies needing antibiotics at birth
mothers who have received antibiotics within 7 days prior to delivery
congenital malformations
chromosomal aberrations
not ready for feeds due to any reason
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Opaque, sealed, coded envelopes will be used for randomization. Neonates of multiple pregnancies will be considered as separate participants. Allocation concealment will be optimized by prescribing allocation only after informed parental consent and recording baseline neonatal data.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group assignment will be allocated by a computer-generated randomization sequence in randomly ordered block sizes of 2 and 4. Opaque, sealed, coded envelopes will be used for randomization.
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
The analysis will be based on the intention to treat principle. Continuous data will be summarized using median, interquartile range and range. Categorical data will be summarised using frequency distributions. Univariate comparisons for continuous data will be made using the Mann Whitney test. For categorical data, the Chi-square or Fisher exact test will be used. SCFA data will be analysed using linear mixed model effects (LME) test to assess differences between the groups over time. In this analysis, subjects will be modelled as a random factor and time and treatment as fixed factors. All tests will be two-sided and a p-value <0.05 will be considered significant. Data on clinical outcomes will be analysed using SPSS version 22.0 statistical software (Armonk, NY: IBM Corp) and SCFA in R (version 3.5.1).
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/01/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
60
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Recruitment hospital [1]
26790
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King Edward Memorial Hospital - Subiaco
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Recruitment postcode(s) [1]
42838
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6008 - Subiaco
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Funding & Sponsors
Funding source category [1]
316949
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Hospital
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Name [1]
316949
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King Edward Memorial Hospital
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Address [1]
316949
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Country [1]
316949
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Australia
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Primary sponsor type
Hospital
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Name
King Edward Memorial Hospital
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Address
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Country
Australia
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Secondary sponsor category [1]
319195
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None
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Name [1]
319195
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Address [1]
319195
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Country [1]
319195
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Ethics approval
Ethics application status
Submitted, not yet approved
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Ethics committee name [1]
315701
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Child and Adolescent Health Service Human Research Ethics Committee
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Ethics committee address [1]
315701
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https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
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Ethics committee country [1]
315701
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Australia
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Date submitted for ethics approval [1]
315701
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26/07/2024
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Approval date [1]
315701
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Ethics approval number [1]
315701
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Summary
Brief summary
Infants born to mothers with gestational diabetes have abnormal gut bacteria, which may predispose them to adverse health outcomes such as inflammatory disorders, allergies, diabetes, obesity, neuro-developmental and neuro-behavioural impairment, cardiovascular and immune-mediated diseases. We aim to supplement these infants with probiotics to alter the bad bacteria with the hope to improve their health outcomes. Currently there are no trials in this area.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
135550
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A/Prof Gayatri Jape
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Address
135550
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King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
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Country
135550
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Australia
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Phone
135550
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+61413441501
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Fax
135550
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Email
135550
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[email protected]
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Contact person for public queries
Name
135551
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Gayatri Jape
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Address
135551
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King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
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Country
135551
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Australia
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Phone
135551
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+61864581260
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Fax
135551
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Email
135551
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[email protected]
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Contact person for scientific queries
Name
135552
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Gayatri Jape
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Address
135552
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King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
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Country
135552
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Australia
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Phone
135552
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+61864581260
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Fax
135552
0
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Email
135552
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Clinical data
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When will data be available (start and end dates)?
After completion of trial recruitment, publication of manuscript (anticipated end 2027) and available for 5 years after publication
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Available to whom?
researchers interested in this aspect of clinical care
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Available for what types of analyses?
systematic review or planning further larger studies
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How or where can data be obtained?
By contacting primary author via email on
[email protected]
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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.
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