Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000210673
Ethics application status
Approved
Date submitted
15/02/2023
Date registered
28/02/2023
Date last updated
16/06/2023
Date data sharing statement initially provided
28/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Development of fermentation ability of infant gut microbiota during weaning
Scientific title
Developmental trajectory of the fermentation ability of infant gut microbiota during weaning
Secondary ID [1] 309034 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut health 328739 0
Condition category
Condition code
Oral and Gastrointestinal 325744 325744 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Changes in gut microbiome composition and fermentation ability along with the introduction of solid foods. Faecal samples and dietary information will be collected at preweaning, early weaning (week 4, week 8 and week 12 after first solid food), and late stage of weaning (around 12 months old). Dietary information will be collected using a paper-based two-day food record and a food frequency questionnaire, which will take approximately 30 minutes to 1 hour to complete.
Intervention code [1] 325242 0
Not applicable
Comparator / control treatment
The preweaning faecal microbiome from each participant will serve as a "comparator" or "baseline" to understand the changes in gut microbiota that occur with the introduction of solid foods at four weaning points. In addition, we will assess the fermentation ability of the faecal microbiota at all points using an in vitro fermentation model. Briefly, infant faecal samples will be used as inocula and pre-digested prebiotics (e.g. BARLEYmax) as substrates in a 24-hour in vitro fermentation model. Fermentation with faecal inocula from the same participants but without the presence of substrate will be used as the experimental control (blank control).
Control group
Active

Outcomes
Primary outcome [1] 333817 0
Feacal microbiota composition assessed using metagenomics
Timepoint [1] 333817 0
Preweaning
Early weaning: Week 4, 8, 12 after the first solid foods
Late weaning stage (~12 months)
Primary outcome [2] 333818 0
Short-chain fatty acids (SCFA) produced during in vitro fermentation (using infant faecal samples as inocula and prebiotics as substrates) will be measured using gas chromatography -flame ionization detector (GC-FID).
Timepoint [2] 333818 0
Preweaning
Early weaning: Week 4, 8, 12 after the first solid foods
Late weaning stage (~12 months)
Secondary outcome [1] 418420 0
Microbial metabolites (metabolome) produced during in vitro fermentation (using infant faecal samples as inocula and prebiotics as substrates) will be assessed using liquid chromatography–mass spectrometry (LC-MS).
Timepoint [1] 418420 0
Preweaning
Early weaning: Week 4, 8, 12 after the first solid food
Late weaning stage (~12 months)

Eligibility
Key inclusion criteria
• Infants at least 4 months old
• Infants have not yet commenced solid food
• Caregiver is willing to collect and provide faecal samples of their children
• Caregiver is willing to complete a study survey and provide their child feeding information
• Live in Adelaide and surrounding areas (within 20 km from Adelaide CBD)
• Caregiver can read and write in English
• Caregiver is willing to provide informed consent on behalf of themselves and their infant
Minimum age
4 Months
Maximum age
7 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Infants born prematurely (gestational age <37 weeks)
• Infants with birth weight <2500g
• Infants had antibiotics since birth
• Have been diagnosed of any medical conditions (e.g. feeding intolerance, gastrointestinal conditions, cystic fibrosis and other genetic defects) that may affect gut microbiome as determined by the Principal Investigator

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The sample size was determined based on significant changes of the primary outcome (short chain fatty acids) in vitro fermentation models.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
4/04/2023
Actual
31/05/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
32
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 313005 0
Government body
Name [1] 313005 0
CSIRO MOSH-FSP
Country [1] 313005 0
Australia
Funding source category [2] 313192 0
Government body
Name [2] 313192 0
CSIRO
Country [2] 313192 0
Australia
Primary sponsor type
Government body
Name
CSIRO
Address
Building 101, Clunies Ross Street
Black Mountain ACT 2601
Australia
Country
Australia
Secondary sponsor category [1] 314691 0
None
Name [1] 314691 0
Address [1] 314691 0
Country [1] 314691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312269 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [1] 312269 0
Building 101, Clunies Ross Street
Black Mountain ACT 2601
Australia
Ethics committee country [1] 312269 0
Australia
Date submitted for ethics approval [1] 312269 0
Approval date [1] 312269 0
28/11/2022
Ethics approval number [1] 312269 0

Summary
Brief summary
The early life microbiome plays a crucial role in immune system development and is associated with various health outcomes later in life. A healthy gut microbiome established in early life can reduce the risk of microbiome-related diseases and promote long-term health benefits. Weaning, the transition to solid foods during early life, particularly complex carbohydrates, is considered a “window of opportunity” for shaping the gut microbiome with its optimal configuration. Introducing prebiotic complementary foods can be an effective strategy for establishing a healthy microbiome during this time. However, the infant gut microbiota at the early weaning stage has limited capability to ferment complex carbohydrates and prebiotic substrates. It remains unclear how and when important carbohydrate fermenting microbes and butyrate producers colonize the infant's gut. To develop an effective and practical strategy for shaping healthy infant gut microbiota, a deeper understanding of the developmental trajectory of gut microbiota and its fermentation ability along with the introduction of solid foods is required.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 124050 0
Dr Yanan Wang
Address 124050 0
CSIRO, Health & Biosecurity, 13 Kintore Ave, Adelaide, SA, 5000
Country 124050 0
Australia
Phone 124050 0
+61883050692
Fax 124050 0
Email 124050 0
yanan.wang@csiro.au
Contact person for public queries
Name 124051 0
Dr Michael Conlon
Address 124051 0
CSIRO, Health & Biosecurity, 13 Kintore Ave, Adelaide, SA, 5000
Country 124051 0
Australia
Phone 124051 0
+61 883038909
Fax 124051 0
Email 124051 0
michael.conlon@csiro.au
Contact person for scientific queries
Name 124052 0
Dr Yanan Wang
Address 124052 0
CSIRO, Health & Biosecurity, 13 Kintore Ave, Adelaide, SA, 5000
Country 124052 0
Australia
Phone 124052 0
+61883050692
Fax 124052 0
Email 124052 0
yanan.wang@csiro.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Need to obtain permission from the institute.


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.