The Safety And Efficacy Of A Probiotic Intervention On Lactulose Hydrogen Breath Test-Positive Patients And Related Gastrointestinal Symptoms
Trial Parameters
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18-65 years old at the inclusion of the study, both female and male subjects. 2. Signed Informed Consent; willing and able to comply with study procedures. 3. Willing to maintain their diet and physical activity levels during the study. 4. Able to swallow a size-00 capsule (23mm length and 9mm width). 5. Participants with at least one of the following Rome IV diagnoses: FABD, functional diarrhea, IBS-M, or IBS-D. 6. Baseline weekly average of worst daily (in past 24 hours) abdominal bloating/distension score of \>= 3.0 on a 0-to-10-point scale. 7. Participants with abnormal LHBT following the North American Consensus recommendations (A rise in hydrogen of ≥20 ppm by 90 min). Exclusion Criteria: 1. History of less than three (3) bowel movements per week. 2. With the diagnosis of IBS-C. 3. Prior gastrointestinal disease, surgery, or abdominal or pelvic radiation treatment which, in the Investigator's opinion, would lead to intestinal structuring or obstruction