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Trial registered on ANZCTR


Registration number
ACTRN12616001052426
Ethics application status
Approved
Date submitted
2/08/2016
Date registered
5/08/2016
Date last updated
5/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
A Randomised, Double-blinded, Placebo-controlled Study of the probiotic PCC(Registered Trademark) (L. fermentum VRI-003) capsule for the effect on gastrointestinal health and gut microflora in healthy adults (with no medically diagnosed gastrointestinal disease)
Scientific title
A proof-of-concept study to investigate the effect of ingestion of the probiotic PCC(Registered Trademark) (L. fermentum VRI-003) or placebo capsules on gut health when given to healthy adults (with no medically diagnosed gastrointestinal disease)
Secondary ID [1] 289814 0
nil
Universal Trial Number (UTN)
Trial acronym
“The BBIG Study” (Bioxyne’s Bacteria in Gut Study)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal health 299740 0
Condition category
Condition code
Oral and Gastrointestinal 299676 299676 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment Arm 1: One capsule of PCC (containing Lactobacillus fermentum VRI-003) once daily for six months. Each active capsule contains a minimum of two billion live organisms.
Treatment Arm 2: One capsule of placebo capsule (containing microcrystalline cellulose, MCC) once daily for six months.

Adherence will be monitored through participant self report on daily diary and through accountability of empty containers/number capsule returned.
Intervention code [1] 295493 0
Treatment: Other
Intervention code [2] 295518 0
Prevention
Comparator / control treatment
One placebo capsule (containing microcrystalline cellulose, MCC) to be taken once daily for six months
Control group
Placebo

Outcomes
Primary outcome [1] 299136 0
Outcome 1: change in the balance of the genera of the gut microbiome

Instrument 1: this will be quantified using 16S RNA analysis of faecal samples

Timepoint [1] 299136 0
Timepoints. assessed at three time points: before commencement of study treatment, 3 months after commencement of study treatment and 6 months after commencement of study treatment
Secondary outcome [1] 326297 0
1. Bowel habit and any bowel issues from daily diary


Timepoint [1] 326297 0
Timepoint: Daily from Screening (up to one week prior to intervention commencement) to final visit (6 months post commencement of intervention).
Secondary outcome [2] 326298 0
2. Use of other medications (based on participant self-report in study diary and at visits)
Timepoint [2] 326298 0
Timepoint: Daily from Screening (up to one week prior to intervention commencement) to final visit (6 months post commencement of intervention).
Secondary outcome [3] 326299 0
3. Quality of Life (SF-36)
Timepoint [3] 326299 0
Timepoint: At screening and at 3 months and 6 months after randomisation
Secondary outcome [4] 326300 0
4. Body Weight (using digital scales)
Timepoint [4] 326300 0
Timepoint: At screening and at 3 months and 6 months after randomisation

Secondary outcome [5] 326301 0
5. Incidence of all adverse events (ie other than GIT) (based on participant self-report in study diary and at study visits) (Note: Strains of L. fermentum and other probiotic are generally regarded as safe (GRAS) and well tolerated, with some bloating and flatulence occurring as the most frequently reported side effects of probiotics in general)
Timepoint [5] 326301 0
Timepoint: Daily from Screening (up to one week prior to intervention commencement) to final visit (6 months post commencement of intervention).
Secondary outcome [6] 328549 0
6. 6-point Likert Scale* assessment of gastric symptoms (ie for any abdominal pain or discomfort, bloating, flatulence / passage of gas and rumbling stomach):
*Never=0
*1 day per month=1
*2-3 days per month=2
*1 day per week=3
*>1 day per week=4
*Every day=5
Timepoint [6] 328549 0
Timepoint: At screening and at 3 months and 6 months after randomisation

Eligibility
Key inclusion criteria
Subject is in general good health with NO history of medically diagnosed gastrointestinal disease.
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any medically diagnosed gastrointestinal disorder/disease (including inflammatory bowel disease, medically diagnosed IBS)
Clinically significant renal, hepatic, endocrine, cardiac, pulmonary, pancreatic, neurologic, haematologic or biliary disorder

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)
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
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)
NSW

Funding & Sponsors
Funding source category [1] 294202 0
Commercial sector/Industry
Name [1] 294202 0
Bioxyne Limited
Address [1] 294202 0
Suite 305, Level 3, 35 Lime Street,
Sydney NSW 2000
Australia
Country [1] 294202 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Bioxyne Limited
Address
Bioxyne Limited
Suite 305, Level 3, 35 Lime Street,
Sydney NSW 2000

Country
Australia
Secondary sponsor category [1] 293035 0
None
Name [1] 293035 0
NA
Address [1] 293035 0
NA
Country [1] 293035 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295610 0
Bellberry Limited
Ethics committee address [1] 295610 0
129 Glen Osmond Road Eastwood South Australia 5063
Ethics committee country [1] 295610 0
Australia
Date submitted for ethics approval [1] 295610 0
03/08/2016
Approval date [1] 295610 0
26/08/2016
Ethics approval number [1] 295610 0

Summary
Brief summary
The complex ecosystem of the adult intestinal microflora is estimated to harbour at least 500 different anaerobic bacterial species. Several reports have indicated that five genera account for most of the viable forms of anaerobic bacteria: Bacteroides, Eubacterium, Bifidobacterium, Peptostreptococcus, and Fusobacterium. Some of these species are considered potentially harmful because of their capacity to produce toxins, invade mucosal cells and activate carcinogens and inflammatory responses. There are, however, known strains with health-promoting properties, principally Bifidobacteria and Lactobacilli.
This study will examine the capacity of a human-isolated probiotic strain of bacteria to influence the composition of the gut microbiome in healthy adult human volunteers and to examine what health benefits may be associated with daily consumption of the strain in the form of freeze-dried powder in capsules. The strain that will be tested in this study is Lactobacillus fermentum VRI-003, referred to as “PCC(Registered Trademark)”. PCC(Registered Trademark) has been sold as a dietary supplement in capsule and powder form for over ten years worldwide with no reported adverse effect.
The study is a proof of concept, single centre, randomised, double-blind placebo controlled, parallel group study. A total of 60 healthy adult subjects (no diagnosed GI disease) will be randomised in a 1:1 ratio to receive either PCC(Registered Trademark) or placebo over a 6 month treatment period. Each active capsule contains a minimum of two billion live organisms.
There will be 4 study visits in total. Subjects will provide three faecal samples: at Visit 2 (baseline, Day 1), Visit 3 (day 90) and Visit 4 (day 180). The samples will be analysed by 16S RNA analysis to monitor the composition of the gut microbiome. Subjects will be asked to complete a daily diary regarding their bowel habits. Subjects will also be asked to complete a general health questionnaire (SF-36) on three occasions. Weight will also be recorded.
Trial website
https://australianclinicaltrials.com/study/probiotic-clinical-trial/
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67914 0
Dr Joanne Grimsdale
Address 67914 0
Oztrials Clinical Research
Suite1, 56-56A Thompson Street
Drummoyne NSW 2047
Australia
Country 67914 0
Australia
Phone 67914 0
+61 2 9719 3852
Fax 67914 0
Email 67914 0
trials@oztrials.com
Contact person for public queries
Name 67915 0
Dr Peter French
Address 67915 0
Bioxyne Limited
Suite 305, Level 3, 35 Lime Street,
Sydney NSW 2000
Australia
Country 67915 0
Australia
Phone 67915 0
+61 2 8296 0000
Fax 67915 0
Email 67915 0
peter.french@bioxyne.com
Contact person for scientific queries
Name 67916 0
Dr Peter French
Address 67916 0
Bioxyne Limited
Suite 305, Level 3, 35 Lime Street,
Sydney NSW 2000
Australia
Country 67916 0
Australia
Phone 67916 0
+61 2 8296 0000
Fax 67916 0
Email 67916 0
peter.french@bioxyne.com

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary