Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12609000281291
Ethics application status
Approved
Date submitted
11/03/2009
Date registered
15/05/2009
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Date results information initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Yogurt Gastrointestinal Upset Reduction Trial for Children on Antibiotics
Scientific title
In children between the age of 1-12 presenting to General Practice who are prescribed oral antibiotics does yogurt with live cultures compared to pasteurised yogurt reduce the incidence of gastrointestinal disturbance as measured by stool frequency and consistency.
Secondary ID [1] 284065 0
Nil known
Universal Trial Number (UTN)
Trial acronym
YoGURT for kids on antibiotics
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal disturbance secondary to oral antibiotics 4446 0
Condition category
Condition code
Alternative and Complementary Medicine 4715 4715 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a double-blind, randomized, placebo-controlled clinical trial intended to evaluate if the use of Vaalia yogurt containing Lactobacillus rhamnosus (LGG), Bifidobacterium lactis Bb-12 (Bb-12) and Lactobacillus acidophilus La-5 (La-5) compared to pasteurised yogurt reduces the incidence of gastrointestinal disturbance in children aged between 1-12 who are on oral antibiotics. Children will be given 100g of Vaalia yogurt 2/day commencing the same day that they start their antibiotic treatment and continuing for the duration of their antibiotic treatment.
The antibiotics will be limited to broad-spectrum antibiotics as prescribed by the participants GP.
Intervention code [1] 4192 0
Prevention
Comparator / control treatment
The same type of yogurt that has been given to the intervention group will be heat treated so that is pasteurized and then administered in the same fashion as the intervention group i.e. 100g 2/day commencing at the time of antibiotic therapy and ceasing when antibiotic therapy ceases.
Control group
Placebo

Outcomes
Primary outcome [1] 5584 0
stool frequency as assessed by the parents or child as appropriate and recorded in a diary
Timepoint [1] 5584 0
one week after ceasing antibiotics
Primary outcome [2] 5585 0
Stool consistency as assessed by the parents or child using the Bristol Stool Scale and recorded in a diary
Timepoint [2] 5585 0
one week after ceasing antibiotics
Secondary outcome [1] 9411 0
Antibiotic dose as recorded by research assistant at time of consent and occurrence of gastrointestinal disturbance as measured by stool frequency and consistency and recorded in diary by parents
Timepoint [1] 9411 0
As measured in the daily diary which will be kept for course of antibiotics plus one week
Secondary outcome [2] 241835 0
Questionnaire: to assess trial and antibiotic compliance and any unexpected events
Timepoint [2] 241835 0
One week after ceasing antibiotic therapy a telephone interview will be conducted with the parents

Eligibility
Key inclusion criteria
Children between the age of 1 and 12 prescribed oral antibiotics
Minimum age
1 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Children will be excluded if they have a history of milk allergy or intolerance, antibiotic treatment within the previous 2 months, prophylactic antibiotic treatment, use of a probiotic product for medicinal purposes within the previous 7 days, immunodeficiency, chronic gastrointestinal disease and acute or chronic diarrhoea

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients presenting to General Practices and pharmacies in the Launceston area. General Practitioners and pharmacists will approach parents who present with children aged 1 year to 12 years old whom have been prescribed oral antibiotics. Parents who elect to participate are randomised to a blinded dose of Vaalia Yogurt containing LGG, BB12 and LA5 or a pasteurized yogurt. To ensure allocation concealment, an independent subject will prepare the randomization schedule and oversee the packaging and labeling of trial treatments. All investigators, participants, outcome assessors and data analysts will be blinded to the assigned treatment throughout the study. Patients presenting to pharmacies in the Launceston area will also be recruited
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Investigators at the University of Tasmania will generate independent allocation sequences and randomization lists for each study site. To avoid a disproportionate number of patients in the experimental or placebo group, randomization at each site will be performed in blocks of six (three received placebo and three, active treatment).
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
Questionnaire at end of trial
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Using Koning et als study (The effect of a multispecies probiotic on the intestinal microbiota and bowel movements in healthy volunteers taking the antibiotic amoxycillin. The American journal of gastroenterology 2008;103(1):178-89.), a t-test (1.5 stools/day, SD .5/day) with a 30% relative reduction in frequency, and power of 80% gave a sample size of 58. As it was planned to use ordinal logistical regression the biostatistician advised a sample size of 70. On review of the data it was decided that poisson analysis, fishers exact, hazard reduction ratios and kaplan meir curves were the most appropriate method of analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/05/2009
Actual
20/09/2009
Date of last participant enrolment
Anticipated
Actual
14/08/2012
Date of last data collection
Anticipated
Actual
30/09/2012
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 4646 0
University
Name [1] 4646 0
Launceston Clinical School, School of Medicine, University of Tasmania
Country [1] 4646 0
Australia
Funding source category [2] 4648 0
Commercial sector/Industry
Name [2] 4648 0
Parmalat Australia Ltd.
Country [2] 4648 0
Australia
Primary sponsor type
Individual
Name
Michael Fox
Address
19 Gorge Road
Trevallyn, Tas, 7250
Country
Australia
Secondary sponsor category [1] 4193 0
University
Name [1] 4193 0
Launceston Clinical School, School of Medicine, University of Tasmania (UTAS)
Address [1] 4193 0
Launceston Clinical School Locked Bag 1377 Launceston. Tasmania. 7250
Country [1] 4193 0
Australia
Secondary sponsor category [2] 287398 0
University
Name [2] 287398 0
School of Human Life Sciences
University of Tasmania
Address [2] 287398 0
Locked Bag 1320
Newnham Campus
Launceston, Tasmania, 7250
Country [2] 287398 0
Australia
Other collaborator category [1] 612 0
Individual
Name [1] 612 0
Kath Ogden
Address [1] 612 0
Launceston Clinical School Locked Bag 1377 Launceston. Tasmania. 7250
Country [1] 612 0
Australia
Other collaborator category [2] 277817 0
Individual
Name [2] 277817 0
Dr. Raj Eri
Address [2] 277817 0
Locked Bag 1320
School of Human Life Sciences
Newnham Campus
University of Tasmania
Launceston, Tas, 7250
Country [2] 277817 0
Australia
Other collaborator category [3] 277818 0
Individual
Name [3] 277818 0
Dr. Kiran Ahuja
Address [3] 277818 0
Locked Bag 1320
School of Human Life Sciences
Newnham Campus
University of Tasmania
Launceston, Tas, 7250
Country [3] 277818 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6683 0
Human Research Ethics Committee (HREC Tas) Network
Ethics committee address [1] 6683 0
Research House,
Private Bag 01
Sandy Bay Campus
Hobart, Tasmania, 7001
Ethics committee country [1] 6683 0
Australia
Date submitted for ethics approval [1] 6683 0
10/03/2009
Approval date [1] 6683 0
02/07/2009
Ethics approval number [1] 6683 0
H0010498

Summary
Brief summary
This study aims to assess if yogurt (containing the probiotics LGG, Bb12 and La5) can reduce the incidence of gastro-intestinal upset associated with antibiotics administration in children aged 1-12
Trial website
Trial related presentations / publications
Young Investigator Finalist presentation presented on 7/10/2013 during Gastroenterological Society of Australia - Australian Gastroenterology week 2013 held at the Melbourne Convention Centre.
Public notes

Contacts
Principal investigator
Name 29374 0
Dr Michael Fox
Address 29374 0
Locked Bag 1320
School Of Human Life Sciences
University of Tasmania
Launceston Tasmania 7250
Country 29374 0
Australia
Phone 29374 0
61 407 000091
Fax 29374 0
Email 29374 0
[email protected]
Contact person for public queries
Name 12621 0
Dr Raj Eri
Address 12621 0
Locked Bag 1320
University of Tasmania
Newnham Campus
Launceston, Tasmania, 7250
Country 12621 0
Australia
Phone 12621 0
+61 3 6324 5467
Fax 12621 0
Email 12621 0
[email protected]
Contact person for scientific queries
Name 3549 0
Dr Raj Eri
Address 3549 0
Locked Bag 1320
University of Tasmania
Newnham Campus
Launceston, Tasmania, 7250
Country 3549 0
Australia
Phone 3549 0
+61 3 6234 5467
Fax 3549 0
Email 3549 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?
Individual data as requested
When will data be available (start and end dates)?
All data will be available until June 2020 then only electronic forms will be available until June 2025
Available to whom?
Researchers
Available for what types of analyses?
As requested
How or where can data be obtained?
[email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
7128Study protocol  [email protected]
7129Statistical analysis plan  [email protected]
7130Informed consent form  [email protected]
7131Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes BMJ Open. 2015 Jan 14;5(1):e006474. doi: 10.1136/b... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseProbiotics for the prevention of pediatric antibiotic-associated diarrhea.2019https://dx.doi.org/10.1002/14651858.CD004827.pub5.
EmbaseCan probiotic yogurt prevent diarrhoea in children on antibiotics? A double-blind, randomised, placebo-controlled study.2015https://dx.doi.org/10.1136/bmjopen-2014-006474
N.B. These documents automatically identified may not have been verified by the study sponsor.