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Trial registered on ANZCTR


Registration number
ACTRN12621001441808
Ethics application status
Approved
Date submitted
24/09/2021
Date registered
25/10/2021
Date last updated
30/01/2023
Date data sharing statement initially provided
25/10/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
The Clinical Evaluation of deactivated Bacillus subtilis BG01-4™ in subjects with Functional Gastrointestinal Disorder (FGID).
Scientific title
The Clinical Evaluation of deactivated Bacillus subtilis BG01-4™ in subjects with Functional Gastrointestinal Disorder (FGID) in relieving symptoms including bloating/gas, diarrhoea and constipations.
Secondary ID [1] 305401 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional abdominal bloating/distension 323762 0
Functional diarrhoea 323763 0
Functional constipation 323764 0
Condition category
Condition code
Oral and Gastrointestinal 321504 321504 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
Participants, who are randomly assigned to the intervention group will be instructed to take 1 sachet per day for the period of 30 days. Each sachet contains 5 billion cells of Bacillus subtilis BG01-4(TM).

As per sachet instructions, all participants are to dissolve all content in one glass of water and consume it immediately.

All remaining sachets to be returned to below address with their unique designated number if not consumed by the end of the trial.
La Trobe University
Vernx Peribiotics Clinical Trial
Reply Paid 93163
Bundoora VIC 3083
Attn: Dr. Anya Shindler
Room 105 The Learning Commons (TLC)
Intervention code [1] 321808 0
Treatment: Other
Comparator / control treatment
Participants, who are randomly assigned to the control group, will be instructed to take 1 sachet per day for a period of 30 days. Each sachet contains non-active ingredients, maltodextrin.
Control group
Placebo

Outcomes
Primary outcome [1] 329061 0
Change in severity of experiencing abdominal bloating/distension using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,

The Gastrointestinal Symptom Rating Scale (GSRS) is a disease-specific questionnaire of 15 items to assess the severity and frequency of symptoms was reported; GSRS uses a 7-point Likert scale ranging from 1 = no problem to 7 = a very severe problem.
Timepoint [1] 329061 0
Changes from Baseline, mid (15th day) and 30th day,
Primary outcome [2] 329063 0
Change in severity of experiencing diarrhoea using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [2] 329063 0
Changes from Baseline, mid (15th day) and 30th day,
Primary outcome [3] 329064 0
Change in severity of experiencing constipation using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [3] 329064 0
Changes from Baseline, mid (15th day) and 30th day,
Secondary outcome [1] 401322 0
The degree of microbiota change assessed using 16S DNA sequencing.
Timepoint [1] 401322 0
Changes from Baseline and 30th day,
Secondary outcome [2] 401351 0
Change in severity of experiencing heartburn using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [2] 401351 0
Changes from Baseline and 30th day,
Secondary outcome [3] 401352 0
Change in severity of experiencing acid reflux using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [3] 401352 0
Changes from Baseline and 30th day,
Secondary outcome [4] 401353 0
Change in severity of experiencing nausea using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [4] 401353 0
Changes from Baseline and 30th day,
Secondary outcome [5] 401354 0
Change in severity of experiencing abdominal pain using Gastrointestinal Symptom Rating Scale (GSRS) to assess the severity and frequency of symptoms,
Timepoint [5] 401354 0
Changes from Baseline and 30th day

Eligibility
Key inclusion criteria
Participants are self-reported functional gastrointestinal disorder in the last 3 months, and have one or more of the following self-reported symptoms experienced for the at least 6 months or longer (meeting the ROME IV criteria for functional gastrointestinal disorder):

a) Recurrent stomach bloating and/or distension occurring on average at least 1 day/week; andabdominal bloating and/or distension predominates over other symptoms, such as minorbowel movement abnormalities.

b) Loose or watery stools, without predominant abdominal pain or bothersome bloating,occurring in more than 25% of stools. (However if you have been diagnosed with IBS-D(diarrhea-predominant IBS) will not be eligible for this study).

c) Functional constipation: straining during more than 25% of defecation per week; sensation ofanorectal obstruction/blockage or incomplete evacuation more than 25% of defecations;needing manual maneuvers (e.g., digital assistance) to help with more than 25% of defecations;loose stools are rare without the use of laxatives.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
a) Participants who had a clinical diagnosis of irritable bowel disease (IBD)
b) Participants who have opioid-induced constipation (OIC).
c) Participants who are intolerant to maltodextrin (food ingredient).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The sachets are packed in identical boxes. Boxes are labelled clearly with different batch codes. The corresponding batch codes of each product is arranged by the manufacturer who pack the sachets for this study,

Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The random sequence is generated using a computer-based random sequence generator.
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/11/2021
Actual
10/03/2022
Date of last participant enrolment
Anticipated
Actual
12/09/2022
Date of last data collection
Anticipated
Actual
30/11/2022
Sample size
Target
66
Accrual to date
Final
67
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 309764 0
Commercial sector/Industry
Name [1] 309764 0
Vernx Biotechnology
Country [1] 309764 0
Australia
Primary sponsor type
Individual
Name
Dr Craig Patch
Address
Vernx Biotechnology
HWT Tower, Level 19, 40 City Road, Southbank, Victoria 3006, Australia
Country
Australia
Secondary sponsor category [1] 310983 0
None
Name [1] 310983 0
Address [1] 310983 0
Country [1] 310983 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309521 0
Bellberry Limited
Ethics committee address [1] 309521 0
123 Glen Osmond Road, Eastwood SA 5063
Ethics committee country [1] 309521 0
Australia
Date submitted for ethics approval [1] 309521 0
06/10/2021
Approval date [1] 309521 0
04/03/2022
Ethics approval number [1] 309521 0

Summary
Brief summary
Irritable Bowel Syndrome is part of a range of disorders classified as a “Functional Gastrointestinal Disorders”. IBS is referred to as a FGID, as the person experiences uncomfortable and often intrusive symptoms; however, on medical investigation (either endoscopy, colonoscopy or other non invasive tests), no medical abnormalities are found. As a result, the issue is regarded as being to do with the functioning of the gut or the gut-brain interaction, rather than organic disease.

This condition may cause intestinal microflora imbalance, and in the long term may lead to constipation, diarrhea, gastroenteritis, gastric ulcer, and other gastrointestinal diseases. Post antibiotic treatment tend to affect the diversity of intestinal microflora, causing diarrhea, flatulence, and nausea. This project aims to observe the effectiveness of deactivated Bacillus subtilis strain BG01-4™ consumption by patients in relieving the gastrointestinal symptoms and restoring their intestinal microflora.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 114442 0
A/Prof Dr Alan Pearce
Address 114442 0
Neuro Sports Labs
Suite 9.06, Level 9, 401 Docklands Drive, Docklands, Victoria, 3008
Country 114442 0
Australia
Phone 114442 0
+610394792860
Fax 114442 0
Email 114442 0
[email protected]
Contact person for public queries
Name 114443 0
Dr Alan Pearce
Address 114443 0
Neuro Sports Labs
Suite 9.06, Level 9, 401 Docklands Drive, Docklands, Victoria, 3008
Country 114443 0
Australia
Phone 114443 0
+610394792860
Fax 114443 0
Email 114443 0
[email protected]
Contact person for scientific queries
Name 114444 0
Dr Craig Patch
Address 114444 0
Vernx Biotechnology
HWT Tower, Level 19, 40 City Road, Southbank, Victoria 3006, Australia
Country 114444 0
Australia
Phone 114444 0
+610394792860
Fax 114444 0
Email 114444 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only the research team will have access to individual level participant data.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13349Ethical approval  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseBacillus Subtilis (BG01-4TM) Improves Self-Reported Symptoms for Constipation, Indigestion, and Dyspepsia: A Phase 1/2A Randomized Controlled Trial.2023https://dx.doi.org/10.3390/nu15214490
N.B. These documents automatically identified may not have been verified by the study sponsor.