The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001607268
Ethics application status
Approved
Date submitted
10/09/2018
Date registered
27/09/2018
Date last updated
29/08/2019
Date data sharing statement initially provided
29/08/2019
Date results information initially provided
29/08/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Survival of probiotic bacteria in the gut of Australian adults
Scientific title
Survival of Lactobacillus Casei Shirota in Australian adults gastrointestinal tract
Secondary ID [1] 296042 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
gastrointestinal function 309594 0
Condition category
Condition code
Oral and Gastrointestinal 308412 308412 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Yakult Fermented Milk Beverage (containing Lactobacillus Casei Shirota 10^8 CFU/ml) - 65ml, once per day for 14 days.
A daily diary will be used to assess compliance.
Intervention code [1] 312381 0
Treatment: Other
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307380 0
Live bacterial LcS count from faecal samples
Timepoint [1] 307380 0
After 1 week of ingestion (i.e once at day 7)
Secondary outcome [1] 351704 0
live bacterial LcS count in faecal samples
Timepoint [1] 351704 0
Following 14 days of ingestion (i.e once at day 14)

Eligibility
Key inclusion criteria
adults 18-40 years of age
BMI: 18.5-29.9
daily bowel movement
Minimum age
18 Years
Maximum age
40 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
history of gastrointestinal disorder (diarrhea, constipation, IBS, IBD, abdominal pain)
disordered requiring a modified diet (eg food allergy/intolerance)
use of antibiotics, laxatives or anti diarrheal medications in the prior 30 days


Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 300631 0
Commercial sector/Industry
Name [1] 300631 0
Yakult Australia
Address [1] 300631 0
Locked Bag 1403
Dandenong South
VIC 3164
Country [1] 300631 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
Parklands Drive
Southport
QLD 4222
Country
Australia
Secondary sponsor category [1] 300142 0
None
Name [1] 300142 0
Address [1] 300142 0
Country [1] 300142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301420 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 301420 0
Griffith University - Bray Centre (N54)
170 Kessels Road, Nathan
QLD 4111
Ethics committee country [1] 301420 0
Australia
Date submitted for ethics approval [1] 301420 0
30/07/2018
Approval date [1] 301420 0
31/07/2018
Ethics approval number [1] 301420 0
2014/537

Summary
Brief summary
Probiotics are defined as live microorganisms which when administered in adequate amount confer a health benefit on the host. The probiotic efficacy relies on their ability to survive in the digestive system and proliferate in the gut. The aim of this study is to investigate the survival of LcS in the intestine of healthy Australian adults after intake of fermented milk (Yakult). A single-arm, open-label study involving 25 otherwise healthy adults will examine the recovery of live culturable bacteria from faecal samples following 7 and 14 days of Yakult ingestion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86934 0
Prof Allan Cripps
Address 86934 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 86934 0
Australia
Phone 86934 0
+61 7 56780321
Fax 86934 0
Email 86934 0
allan.cripps@griffith.edu.au
Contact person for public queries
Name 86935 0
Prof Allan Cripps
Address 86935 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 86935 0
Australia
Phone 86935 0
+61 7 56780321
Fax 86935 0
Email 86935 0
allan.cripps@griffith.edu.au
Contact person for scientific queries
Name 86936 0
Prof Allan Cripps
Address 86936 0
Griffith University
Parklands Drive
Southport QLD 4222
Country 86936 0
Australia
Phone 86936 0
+61 7 56780321
Fax 86936 0
Email 86936 0
allan.cripps@griffith.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
individual level data has been reported in the manuscript
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
Yes
Journal publication details
Publication date and citation/details [1] 4306 0
AJ Cox, H Makino, AW Cripps, NP West. Recovery of Lactobacillus casei strain Shirota (LcS) from faeces with 14 days of fermented milk supplementation in healthy Australian adults. Asia Pacific Journal of Clinical Nutrition. (in press, accepted 12 August 2019).
Attachments [1] 4306 0
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary