Trial Review

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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
Scientific title
Evaluation of Faecal microbiota following PRobiotics in Infants of Mothers with Diabetes (PRIMD) trial: a double-blind placebo-controlled pilot randomized trial
Secondary ID [1] 312525 0
nil known
Universal Trial Number (UTN)
Trial acronym
PRIMD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Infants of mothers with gestational diabetes 334397 0
Condition category
Condition code
Oral and Gastrointestinal 331038 331038 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Metabolic and Endocrine 331090 331090 0 0
Diabetes
Reproductive Health and Childbirth 331091 331091 0 0
Complications of newborn

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 329041 0
Treatment: Other
Comparator / control treatment
Control group will receive placebo (dextrin) with similar weight and packaging as the probiotic
Control group
Placebo

Outcomes
Primary outcome [1] 338798 0
Faecal microbiota at birth or first week of life and at 4 months of age after supplementation
Timepoint [1] 338798 0
timepoint 1 (T1: at birth or in first week of life) and timepoint 2 (T2: after 4 months of supplementation before starting weaning)
Secondary outcome [1] 437506 0
Faecal short chain fatty acids (butyrate, acetate, propionate) as one of composite secondary outcomes
Timepoint [1] 437506 0
T1 (timepoint 1: within first week of birth) and T2 (timepoint 2: after 4 months of intervention with placebo or probiotic before starting weaning)
Secondary outcome [2] 437507 0
Growth parameters (weight) in kg
Timepoint [2] 437507 0
At birth, 4, 12 and 24-months of age
Secondary outcome [3] 437508 0
Developmental data
Timepoint [3] 437508 0
4,12 and 24-months of age
Secondary outcome [4] 437710 0
Growth (length) in cms
Timepoint [4] 437710 0
at 4,12 and 24-months of age
Secondary outcome [5] 437711 0
Growth (head circumference) in cms
Timepoint [5] 437711 0
at 4, 12 and 24-months of age
Secondary outcome [6] 437712 0
Developmental data specific for social-emotional development
Timepoint [6] 437712 0
at 4,12 and 24 months of age

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
Minimum age
1 Days
Maximum age
120 Days
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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.
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.
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
Safety/efficacy
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).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/01/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 26790 0
King Edward Memorial Hospital - Subiaco
Recruitment postcode(s) [1] 42838 0
6008 - Subiaco

Funding & Sponsors
Funding source category [1] 316949 0
Hospital
Name [1] 316949 0
King Edward Memorial Hospital
Country [1] 316949 0
Australia
Primary sponsor type
Hospital
Name
King Edward Memorial Hospital
Address
Country
Australia
Secondary sponsor category [1] 319195 0
None
Name [1] 319195 0
Address [1] 319195 0
Country [1] 319195 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 315701 0
Child and Adolescent Health Service Human Research Ethics Committee
Ethics committee address [1] 315701 0
https://cahs.health.wa.gov.au/Research/For-researchers/Ethics-and-governance-approval
Ethics committee country [1] 315701 0
Australia
Date submitted for ethics approval [1] 315701 0
26/07/2024
Approval date [1] 315701 0
Ethics approval number [1] 315701 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 135550 0
A/Prof Gayatri Jape
Address 135550 0
King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
Country 135550 0
Australia
Phone 135550 0
+61413441501
Fax 135550 0
Email 135550 0
[email protected]
Contact person for public queries
Name 135551 0
Gayatri Jape
Address 135551 0
King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
Country 135551 0
Australia
Phone 135551 0
+61864581260
Fax 135551 0
Email 135551 0
[email protected]
Contact person for scientific queries
Name 135552 0
Gayatri Jape
Address 135552 0
King Edward Memorial Hospital, 374 Bagot road, Subiaco, WA, 6008
Country 135552 0
Australia
Phone 135552 0
+61864581260
Fax 135552 0
Email 135552 0
[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?
Clinical data
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
Available to whom?
researchers interested in this aspect of clinical care
Available for what types of analyses?
systematic review or planning further larger studies
How or where can data be obtained?
By contacting primary author via email on [email protected]


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.