None listed
Conditions
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.
Interventions
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 Peribioti
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)
Sponsors
Dr Craig Patch
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
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.
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).
Outcome results
None listed