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.
The goal of this double-blinded, randomized, placebo-controlled clinical study is to evaluate whether two different doses of a probiotic formulation may have effect on gastrointestinal symptoms, as well as gut and small intestine microbiota, in participats suffering from SIBO. The two probiotic doses will be compared to a placebo. The main research questions to be answered by this study are related to: * Probiotic effect on bloating and abdominal distension. * Probiotic effect on other gastrointestinal symptoms. * Probiotic effect on incidence of SIBO. * Probiotic effect on small intestine and gut microbiota. The study will include a 2 month intervention with the investigational products and assessments will be conducted at baseline, mid-intervention, end-of-intervention, and follow-up period, with the exception of SIBO diagnosis, which will be conducted at baseline and at follow-up.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
105
The intervention consists of a probiotic either with a low or high dosage
Nimble Science
Calgary, Alberta, Canada
RECRUITINGChange 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.
Time frame: From baseline to end of intervention (week 8).
Median bloating-free days
Median bloating-free days per week at each intervention week and follow up
Time frame: Each intervention week and follow up (week 12) compared to baseline.
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)
Time frame: At all intervention weeks (with the exception of end-of-intervention, as described in the primary outcome) and follow-up (week 12) compared to baseline.
Change in abdominal discomfort/pain
Change in abdominal discomfort/pain assessed by an ordinal scale (0 no pain - 10 extreme pain)
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline
Changes in gastrointestinal symptoms
Changes in gastrointestinal symptoms assessed with GSRS
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Changes in stool frequency and consistency
Changes in stool frequency and consistency assessed with the Bristol Stool Scale (scoring 1 watery - 7 hard)
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Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Changes in the quality of life
Changes in the quality of life assessed with the Short Form (SF)-36 questionnaire
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Changes in reflux incidence and severity
Changes in reflux incidence and severity assessed with the modified reflux symptoms (mRESQ)
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Changes in the severity of IBS symptoms
Changes in the severity of IBS symptoms assessed with IBS Severity Scoring System (IBS-SSS) questionnaire
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Recovery rate of the probiotic strain
Recovery rate of the probiotic strain in small intestine and stool specimens
Time frame: At mid-intervention (week 4) end of intervention (week 8), and follow-up (week 12) compared to baseline.
Microbiome changes within small intestine, fecal and saliva samples
Changes in the the bacterial populations with the small intestine, fecal and saliva microbiomes represented as a diversity ratio
Time frame: At mid-intervention (week 4), end of intervention (week 8), and follow-up (week 12) compared to baseline.
Investigation how the microbiome and SIBO associate with each other though bacterial population analyses.
Exploring the correlation of select bacterial populations with SIBO through analysis of the small intestine and fecal microbiomes using metagenomics methodologies.
Time frame: Through study completion, an average of 1 year
Change in SIBO positivity rate
Change in SIBO positivity rate assessed by glucose breath test
Time frame: Through study completion, an average of 1 year