SIMBA in Irritable Bowel Syndrome (IBS)

Ki vehet részt

• Age 18-65 years at the inclusion of the study, both female and male subjects
• Provide informed consent to participate in study; willing and able to comply with study procedures
• Able to swallow a capsule sized 25mm length and 9mm width (i.e. large dose omega 3 pill)
• Willing to maintain their diet and physical activity levels during the study
• Participants with a confirmed or suspected diagnosis of Irritable Bowel Syndrome (IBS) meeting or presenting with symptoms consistent with Rome V criteria for one of the following subtypes: IBS-C, IBS-M, or IBS-D
• Baseline weekly average of worst daily (in past 24 hours) abdominal bloating score of >= 3.0 on a 0-to-10-point scale

Ki nem vehet részt

• Regular use of probiotics, prebiotics or synbiotics (including food and drinks containing added probiotics and/or probiotic yogurts with live, active cultures, or kefir) within 1 month prior to screening. Non-probiotic fortified yogurt is acceptable. Potential participants may be eligible once a 1-month washout is completed
• Stimulant laxative use (includes bisacodyl/Dulcolax, senna/Senekot, cascara, or fiber supplements) is allowed if it is kept unchanged in the week prior to the SIMBA capsule ingestion. Osmotic laxatives (polyethylene glycol (PEG; other trade names), milk of magnesia, lactulose), stool softeners (docusate; other trade names) or secretagogues (linaclotide/Constella, plecanatide/Trulance, tenapanor/Ibsrela should not be used within 7 days of taking the SIMBA capsules
• Use of oral or intravenous antibiotics or antifungal medications (except topical antibiotics or antifungals) within the previous 12 weeks. This includes rifaximin
• Use of medications known to affect gastrointestinal motility, including but not limited to prokinetics (including domperidone, metoclopramide, prucalopride), anticholinergics, opioids, GLP-1 receptor agonists, secretagogues (linaclotide, plecanatide, tenapenor), cholestyramine, colchicine, and methyldopa, unless permitted by protocol
• Chronic use of salicylates, aspirin (ASA), corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), misoprostol or other medications known to affect small intestinal mucosal integrity, as determined by the Principal Investigator
• Alcohol consumption >21 units per week, alcohol abuse, or illicit drug use
• Participation in another clinical trial within 30 days prior to enrollment
• Major surgery within the previous 3 months
• Prior fecal microbiota transplantation, less than a year before study enrollment
• Cancer diagnosis or treatment within the past year (except non-melanoma skin cancer); Concomitant Supplements Participants taking supplements that are judged by the investigators not to interfere with study outcomes (e.g., vitamins, omega-3 fatty acids, creatine monohydrate) may continue use, provided the dose remains unchanged throughout the study, are not taken within 6 hours on either side of capsule ingestion, and no new supplements are introduced unless medically recommended; Pregnancy Assessment Females of childbearing potential will be assessed for pregnancy risk through self-report. A urine β-hCG test will be required if pregnancy status is uncertain. Participants who become pregnant during the study will discontinue the study medication immediately and notify the investigators
• Known allergy or hypersensitivity to rifaximin
• Any significant medical condition that, in the opinion of the Principal Investigator or Qualified Investigator, could interfere with study participation, intervention, or outcome assessment, including:; Renal disease; Gastrointestinal disorders (includes inflammatory bowel disease, celiac disease (treated or untreated), any eosinophilic gastrointestinal disorder, microscopic colitis); Autoimmune disease (including Rheumatoid arthritis, lupus, scleroderma); Metabolic disease (type 1 diabetes is excluded. Controlled Type 2 diabetes may be acceptable per investigator's discretion); Cardiovascular or vascular disease; Respiratory disease (COPD, home oxygen use is excluded. Mild asthma (prn puffer use) may be acceptable); major mental health disorder; Hyperthyroidism (whether controlled or not). Controlled hypothyroidism is allowable
• Non-English speaking
• Current smoker or use of tobacco, nicotine, or cannabis products including vapes, gums, gummies, or other ingestible or inhaled formats
• Currently dieting for weight loss or following a low-carbohydrate diet
• Pregnancy, lactation, planned pregnancy during the study period, or unwillingness to use an approved method of contraception if of childbearing potential