Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001136695
Ethics application status
Approved
Date submitted
10/10/2014
Date registered
27/10/2014
Date last updated
21/12/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Probiotic microflora in the gut following ingestion of fermented milk.
Scientific title
Recovery of faecal Lactobacillus casei strain Shirota (LcS)
from the Intestine of Healthy Adults after Intake of Fermented Milk.
Secondary ID [1] 285455 0
Nill known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gut microbia in community dwelling adults 293226 0
Condition category
Condition code
Inflammatory and Immune System 293495 293495 0 0
Normal development and function of the immune system
Oral and Gastrointestinal 293574 293574 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily ingestion of a single dose (1 bottle, 65mL) of a commercially available fermented milk product (Yakult), containing 6.5 billion Lactobacillus casei Shirota strain (probiotic) per bottle, for 14 days. Participants will be asked to complete a daily questionnaire to provide details on adherence.
Intervention code [1] 290389 0
Treatment: Other
Comparator / control treatment
Participants will undertake a 14 day baseline washout period where no probiotic supplements are ingested.

Participants will undertake a 14 day follow up period where no probiotic supplements are ingested.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293316 0
Recovery of Lactobacillus casei Shirota (LcS) in faeces. LcS will be analysed using culture method (FOM-LLV) and ELISA.
Timepoint [1] 293316 0
Faecal samples will be analysed at four (4) time-points; 14 days after cessation of probiotic products (baseline); 7 days into the ingestion period (ingestion period 1); 14 days into the ingestion period (ingestion period 2); and 14 days after the ingestion period (follow up).
Secondary outcome [1] 310789 0
Stool consistency. Subjects will rate stool consistency based on the Bristol Stool Form Scale and report the findings in a daily participant diary.
Timepoint [1] 310789 0
Each day during the 42 day trial.
Secondary outcome [2] 310904 0
Number of bowel movements per day. Subjects will report the findings in a daily participant diary.
Timepoint [2] 310904 0
Each day during the 42 day trial.

Eligibility
Key inclusion criteria
Community dwelling adults
Minimum age
18 Years
Maximum age
35 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Body mass index less than 18.5 or above 25 kg/m2.
History of gastrointestinal disorders (constipation, diarrhea, abdominal pain, irritable bowel syndrome).
Disorders requiring a special diet.
Respiratory or gastrointestinal illness in the 30 days prior to the study.
Use of systemic antibiotics or antimycotics medication in the 30 days prior to the study.
Use of antidiarrheal or laxative medications in the 30 days prior to the study.
History of asthma or allergies.
Use of immunomodulating medications and participation in any other studies within 2 months prior to entry into the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.

All subjects undergo the treatment (ingestion of a commercially available fermented milk product).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Within subject repeated measures analysis to ascertain the mean effect and 95% confidence intervals. The sample size was chosen based on previous research reporting an increase in Lactobacillus casei strain Shirota after ingestion of fermented milk containing the probiotic for 10-14 days (J Med Assoc Thai. (2012) 95 S42-7; European Journal of Clinical Nutrition (1998) 52, 899-907). A power calculation based on the results from these studies (using and alpha of 0.01 and a desired power of .90) suggests a sample size of 25 will be sufficient to detect statistical significance.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/10/2014
Actual
24/10/2014
Date of last participant enrolment
Anticipated
Actual
24/10/2014
Date of last data collection
Anticipated
Actual
12/12/2014
Sample size
Target
25
Accrual to date
Final
25
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 290067 0
Commercial sector/Industry
Name [1] 290067 0
Yakult Honsha Co., LTD.
Country [1] 290067 0
Japan
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road, Nathan, QLD 4111
Country
Australia
Secondary sponsor category [1] 288756 0
Commercial sector/Industry
Name [1] 288756 0
Yakult Honsha Co., LTD.
Address [1] 288756 0
1-19 Higashi Shimbashi 1-chrome,
Minato-ku, Tokyo 105-8660
Country [1] 288756 0
Japan

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291771 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 291771 0
Ethics committee country [1] 291771 0
Australia
Date submitted for ethics approval [1] 291771 0
22/07/2014
Approval date [1] 291771 0
25/09/2014
Ethics approval number [1] 291771 0
AHS/37/14/HREC

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 51922 0
Prof Allan Cripps
Address 51922 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 51922 0
Australia
Phone 51922 0
+61 7 5678 0809
Fax 51922 0
Email 51922 0
[email protected]
Contact person for public queries
Name 51923 0
Nicholas west
Address 51923 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 51923 0
Australia
Phone 51923 0
+61419649447
Fax 51923 0
Email 51923 0
[email protected]
Contact person for scientific queries
Name 51924 0
Nicholas west
Address 51924 0
Griffith Health Centre, Griffith University, Gold Coast Campus, Parklands, QLD 4222
Country 51924 0
Australia
Phone 51924 0
+61419649447
Fax 51924 0
Email 51924 0
[email protected]

No information has been provided regarding IPD availability


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.