Status:
TERMINATED
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
Lead Sponsor:
AB Biotics, SA
Conditions:
Irritable Bowel Syndrome
Small Intestinal Bacterial Overgrowth
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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 Bowe...
Detailed Description
Irritable Bowel Syndrome (IBS) is a functional gastrointestinal disease in which recurrent abdominal pain is associated with defecation or a change in bowel habits. Disordered bowel habits are typical...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 20 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2022
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT04316806
Start Date
November 20 2020
End Date
September 1 2022
Last Update
November 8 2022
Active Locations (1)
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1
Dr. Bofill Clinic
Girona, Spain, 17002