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Trial registered on ANZCTR


Registration number
ACTRN12618000927224
Ethics application status
Approved
Date submitted
25/05/2018
Date registered
31/05/2018
Date last updated
13/02/2019
Date data sharing statement initially provided
13/02/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Phase 1 clinical trial evaluating whether probiotic supplementation prevents chemotherapy-induced diarrhoea and other intestinal adverse effects in cancer patients.
Scientific title
The safety and tolerability of a multi-species probiotic formulation in chemotherapy-induced intestinal mucositis/diarrhoea/neutropenia: an exploratory end-point pilot study
Secondary ID [1] 294996 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 308016 0
Diarrhoea 308072 0
Neutropenia 308074 0
Condition category
Condition code
Cancer 307122 307122 0 0
Any cancer
Oral and Gastrointestinal 307123 307123 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention:
MultiBiotic probiotic formulation containing per capsule:
Lactobacillus rhamnosus (Med 26) 9 billion CFU
Lactobacillus acidophilus (Med 27) 3.75 billion CFU
Lactobacillus plantarum (Med 25) 1.575 billion CFU
Bifidobacterium animalis spp. lactis (Med 13) 3 billion CFU
Bifidobacterium breve (Med 12) 1.75 billion CFU
Bifidobacterium bifidum (Med 11) 500 million CFU
Streptococcus thermophilus (Med 51) 1.5 billion CFU
Total 21.075 Billion CFU* / 1 capsule

Dosage: 2 capsules twice daily.
Mode of administration: oral
Duration of intervention: 12 weeks
Monitoring: Drug bottles returned (empty or not) to trial investigator.
Intervention code [1] 301338 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306023 0
A composite primary outcome of physical, social, emotional and functional well-being (33 items) will be evaluated according to the FACT-C scale.
The primary outcome will be the mean change in the FACT C total score (33-item) between baseline and end of of the study (12 weeks).
Timepoint [1] 306023 0
Participants Research Diary collected at the end of the study (12 weeks)
Primary outcome [2] 306024 0
Mean change in Bristol Stool scores between baseline and end of the study (12 weeks).
Timepoint [2] 306024 0
Participants Research Diary collected at the end of the study (12 weeks)
Primary outcome [3] 306025 0
Mean changes in blood lipopolysaccharide between baseline and end of three chemotherapy cycles.
Timepoint [3] 306025 0
Blood drawn at baseline and the end of the study (12 weeks).
Secondary outcome [1] 347381 0
The extent of use of antidiarrhoeal rescue medication.
Participants Research Diary collected at the end of the study
Timepoint [1] 347381 0
End of the study (12 weeks).
Secondary outcome [2] 347382 0
Changes in a subjects’ faecal microbiota from baseline to end of study.
Stool sample collected at baseline and the end of the study (12 weeks).
Timepoint [2] 347382 0
End of the study (12 weeks).
Secondary outcome [3] 347383 0
Changes in level of lipopolysaccharide (LPS).
Blood drawn at baseline and the end of the study (12 weeks).
Timepoint [3] 347383 0
End of the study (12 weeks).

Eligibility
Key inclusion criteria
Adult patient diagnosed with cancer and who are chemotherapy naïve or about to commence a new chemotherapy regimen due to disease progression
Life expectancy more than 12 months
Absence of any psychological, familial, sociological or geographical conditions, which could potentially hamper compliance with the study protocol and follow-up schedule;
Willingness to comply with the study.
Signed and written informed consent
Minimum age
18 Years
Maximum age
75 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Active infection treated by antibiotic therapy
Ileostomy
Hypersensitivity to study drug
Any concurrent malignancy other than non-melanoma skin cancer, no other cancer in past 5 years.
Serious concomitant systemic disorders or diseases incompatible with the study
Patient has a history of primary psychological disorder
Illicit drug use

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)
Allocation is not concealed
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
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
The presence of diarrhoea will be evaluated according to the CTCAE toxicity score. Stool consistency will be evaluated according to the Bristol Stool Scale. Physical, social, emotional and functional well-being will be evaluated according to the FACT-C scale.
For the primary outcome of safety and tolerability the results will be descriptive and quantitative. The daily stool score will be the mean of all the daily assessments. The change in mean stool scores from baseline to the end of treatment will be analyzed using analysis of covariance (ANCOVA), with baseline pain as a covariate and grouped study and treatment as factors. Use of antidiarrhoea medication (during treatment) will be recorded and analyzed using ANCOVA.

Recruitment
Recruitment status
Not yet recruiting
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)
NSW
Recruitment hospital [1] 11001 0
Northern Cancer Institute - St Leonards
Recruitment postcode(s) [1] 22790 0
2065 - St Leonards

Funding & Sponsors
Funding source category [1] 299582 0
Commercial sector/Industry
Name [1] 299582 0
Medlab Clinical
Address [1] 299582 0
Medlab Clinical LTD
66 McCauley Street
Alexandria, NSW
Australia 2015
Country [1] 299582 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Medlab Clinical
Address
Medlab Clinical LTD
66 McCauley Street
Alexandria, NSW
Australia 2015
Country
Australia
Secondary sponsor category [1] 298897 0
None
Name [1] 298897 0
Address [1] 298897 0
Country [1] 298897 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300483 0
National Institute of Integrative Medicine HREC
Ethics committee address [1] 300483 0
11-23 Burwood Road
Hawthorn
Vic 3122
Ethics committee country [1] 300483 0
Australia
Date submitted for ethics approval [1] 300483 0
04/10/2017
Approval date [1] 300483 0
16/11/2017
Ethics approval number [1] 300483 0
0043E_2017

Summary
Brief summary
The purpose of this study is to test the safety and tolerability of the MultiBiotic probiotic formulation before starting chemotherapy and until the end of treatment.

Who is it for?
You may be eligible for this study if you are an adult who has been diagnosed with cancer and have not yet commenced chemotherapy.

Study details
Patients who decide to take part in this trial will be given probiotic (friendly gut bacteria) capsules to be taken daily before and during the duration of the chemotherapy.
The probiotic has been developed to support gastrointestinal health. It contains three species of Lactobacilli, three species of Bifidobacterium and one species of Streptococcus bacteria.
Participants will be asked about their general wellbeing at the beginning and at the end of the study. They will also be asked to keep a record of intestinal symptoms. A stool and a blood test will be required at beginning and at the end of the study.
Chemotherapy is associated with mucositis manifesting as pain, inflammation, diarrhoea, weight loss, and infection.
It is hoped that this research will help improve the general wellbeing of patients during chemotherapy.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83802 0
Prof Stephen Clarke
Address 83802 0
Northern Cancer Institute,
Level 1/38 Pacific Highway,
St Leonards, NSW 2065
Country 83802 0
Australia
Phone 83802 0
+61 2 9437 1900
Fax 83802 0
Email 83802 0
stephen.clarke@sydney.edu.au
Contact person for public queries
Name 83803 0
Ms Serena Del Forno
Address 83803 0
Medlab Clinical LTD
66 McCauley Street
Alexandria, NSW
Australia 2015
Country 83803 0
Australia
Phone 83803 0
+61 2 8188 0311
Fax 83803 0
Email 83803 0
serena_dalforno@medlab.co
Contact person for scientific queries
Name 83804 0
A/Prof Luis Vitetta
Address 83804 0
Medlab Clinical LTD
66 McCauley Street
Alexandria, NSW
Australia 2015
Country 83804 0
Australia
Phone 83804 0
+61 2 8188 0311
Fax 83804 0
Email 83804 0
luis_vitetta@medlab.co

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results