Testing Probiotic for small intestinal bacterial overgrowth

Exclusion

• −Allergy to the components present in the probiotic and placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → capsules.
• −History or diagnosis of immunological diseases, infectious diseases or immune-compromised conditions, which in the opinion of the investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →, would adversely affect study safety or outcome. Such as, but not limited to, hepatitis, tuberculosis, HIV positive, Parkinson's, multiple sclerosis, AIDS, lymphoma, and long-term corticosteroid treatment.
• −History of less than three (3) bowel movements per week.
• −With the diagnosis of IBS-C.
• −Persons with central venous catheters.
• −History of known structural gastrointestinal abnormalities such as structures or fistulas leading to mechanical obstruction.
• −Use of any medications in the week prior to the screeningScreeningThe checks done before joining, to see whether a study fits.Read more → study visit, unless part of regular treatment, that could substantially alter gastrointestinal motor function (e.g., opioids, anticholinergics, or GLP-1 analogues); laxative use is allowed if used less than 3 times a week and it is willing to keep unchanged in the week prior to the SIMBA capsule ingestions. Proton pump inhibitors (PPIs) are allowed provided a wash-outWashout periodA gap with no treatment, so the previous one clears your system.Read more → period of 48 hours is respected before swallowing the SIMBA capsules and PPI treatment is resumed only 4 hours thereafter.
• −o Prokinetic use. Potential participants who are not using prokinetics to treat SIBO may be eligible after a 2-week washout period, and willing to not use prokinetics for the study duration.
• −Unable to stop using laxatives or prokinetic medications for 4 days before the study procedure (BT). Laxatives can be resumed after the test is conducted.
• −Organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome.
• −Celiac disease (treated or untreated).
• −Any significant heart, liver, lung, kidney, blood, endocrine or nervous system disease, which in the opinion of the investigator, would adversely affect study safety or outcome.
• −Cancer diagnosis or treatment within the past year (non-melanoma skin cancers are acceptable).
• −Gastrointestinal inflammatory diseases, including ulcerative colitis, Crohn's disease, microscopic colitis.
• −Participants with IBS presenting with alarm symptoms such as: rectal bleeding, unexplained weight loss, iron deficiency anemia, and nocturnal symptoms,
• −Participants over the age of 50 or older who have not had:
• −a colon cancer screening by either a negative FIT or FOBT test within the last 2 years; OR
• −a colonoscopy in the prior 10 years which was negative for colorectal cancer
• −Epilepsy diagnosis.
• −History of oropharyngeal dysphagia, or other swallowing disorder with a risk of capsule aspiration.
• −Antibiotic use (except for topical use) ≤ 12 weeks prior to screening. Potential participants may be eligible once a 12-week washout is completed.
• −Regular use of probiotics, prebiotics or synbiotics (including food and drinks containing added probiotics and/or probiotic yogurts with live, active cultures) within 1 month prior to screening. Potential participants may be eligible once a 1-month washout is completed.
• −Any prior Fecal Microbiota Transplantation.
• −Alcohol or drug abuse.
• −Are non-English speaking.
• −Are scheduled for an MRI at any time during the study. Potential participants may be eligible to participate once their MRI procedure is completed.
• −Pregnant or breastfeeding.
• −Planning to become pregnant.
• −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.
• −Known history abdominal radiation treatment.