The goal of this study is to test the effect of a probiotic formulation on gastrointestinal symptoms, gut and small intestine microbiota in participants suffering from small intestinal bacterial overgrowth (SIBO). Two doses of probiotic will be evaluated against placebo.
Aged 18-65 years old at the inclusion of the study, both female and male subjects.
Signed Informed Consent; willing and able to comply with study procedures.
Willing to maintain their diet and physical activity levels during the study.
Able to swallow a size-00 capsule (23mm length and 9mm width).
History of less than three (3) bowel movements per week.
With the diagnosis of IBS-C.
Prior gastrointestinal disease, surgery, or abdominal or pelvic radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction with a risk of capsule non-excretion, including, e.g., achalasia, eosinophilic esophagitis, any IBD, or previous esophageal, gastric, small intestinal, or colonic surgery. Appendectomy or cholecystectomy more than 3 months before the screening visit is acceptable.
Persons with central venous catheters.
Parallel
Probiotic
Dietary supplementThe intervention consists of a probiotic either with a low or high dosage
Change in bloating/distension severity
The primary outcome will assess the changes in weekly median severity of bloating/distension, defined as pressure, fullness or sensation of increased girth with a daily assessment with an ordinal scale between probiotic groups and placebo.
Median bloating-free days
Median bloating-free days per week at each intervention week and follow up
Change in median bloating/distension severity
Change in median bloating/distension severity assessed by an ordinal scale (0 no severity- 10 extreme severity) at all intervention weeks (with the exception of end-of-intervention, as described in the primary outcome)
Change in abdominal discomfort/pain
Change in abdominal discomfort/pain assessed by an ordinal scale (0 no pain - 10 extreme pain)
Changes in gastrointestinal symptoms
Changes in gastrointestinal symptoms assessed with GSRS
Exploratory metabolomic analysis
To investigate whether certain metabolites present in the small intestine, fecal, saliva samples may be associated with the presence/absence of SIBO. Using untargeted metabolomic methodologies.
Exploratory: Quantifying the probiotic cell proportions
Determine the proportion of probiotic cells in spore versus germinated form using qPCR methodologies
Safety outcomes
To collect safety data on the probiotic formulation and the SIMBA capsule by monitoring adverse events throughout the study.
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Nimble Science Ltd.
Lead sponsor
Lallemand Health Solutions
Collaborator
