Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

• Status: Recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AB Biotics, SA
• Treatments: Anti-Bacterial Agents; Rifaximin

Criteria

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.