Effect of a Probiotic Formula on Reducing SIBO in IBS Patients (NCT04316806) | Clinical Trial Compass
TerminatedNot Applicable
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
Stopped: Principal Investigator changed his job
Spain8 participantsStarted 2020-11-20
Plain-language summary
This randomized study evaluates the effectiveness of the a probiotic formula, compared with the antibiotic rifaximin, in the treatment of Small Intestinal Bacterial Overgrowth (SIBO) in Irritable Bowel Syndrome (IBS) patients.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
* Patients diagnosed with IBS according to Rome IV criteria (Lacy et al. Gastroenterology 2016) and with SIBO according to North American Consensus (Rezaie et al., Am J Gastroenterol. 2017), providing Informed Consent.
Patients taking set doses of Proton Pump Inhibitors (PPIs) or antispasmodics can be included.
Exclusion Criteria:
* Use of antibiotics in the 4 weeks before study initiation.
* Use of probiotics in the 2 weeks before study initiation.
* Use of loperamide or other prokinetics in the week before study initiation.
* Use of Plantago ovata, lactulose or other laxans in the week before study initiation.
* Use of antidepressants.
* Suspicion or confirmed diagnose of coeliac disease, inflammatory bowel disease (IBD), symptomatic diverticulosis/diverticulitis, or endometriosis.
* Previous intestinal surgery, except appendectomy and herniorrhaphy.
* Short bowel syndrome or pancreatitis.
* Concomitant treatment with immunosuppressors, oncologic disease, severe cardiovascular disease, positive for HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV).
* Other conditions that can interfere with the effect of probiotic.
* Pregnant or lactating women.