Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Efficacy of a Probiotic Formula in Reducing Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)

Sponsors

Lead Sponsor: AB Biotics, SA

Source AB Biotics, SA
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 Bowel Syndrome (IBS) patients.

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 typically present (ie, constipation, diarrhea, or a mix of constipation and diarrhea), as are symptoms of abdominal bloating/distention. IBS pathophysiology is multifactorial and may include alterations of the gut microbiota, food intolerances and Small Intestinal Bacterial Overgrowth (SIBO). However, SIBO is a distinct entity than IBS, as patients can present SIBO without IBS. SIBO is diagnosed based on objective tests (breath test or microbial culture of duodenal aspirate) while IBS is a functional syndrome, diagnosed on symptoms (Rome-IV criteria). A probiotic formula composed of strains Pediococcus acidilactici CECT 7483 and Lactobacillus plantarum CECT 7484 and CECT 7485 was previously shown to improve quality of life in patients with IBS. Rifaximin is a a non-absorbable antibiotic commonly used for the treatment of SIBO.

Overall Status Recruiting
Start Date 2020-11-20
Completion Date 2022-07-01
Primary Completion Date 2022-04-01
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
SIBO 0 and 4 weeks
Secondary Outcome
Measure Time Frame
Gut microbiota 0 and 4 weeks
IBS severity 0, 4 and 8 weeks
Intestinal related anxiety 0, 4 and 8 weeks
Global improvement after treatment 8 weeks
Enrollment 40
Condition
Intervention

Intervention Type: Dietary Supplement

Intervention Name: Probiotic

Description: Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)

Arm Group Label: Probiotic

Intervention Type: Drug

Intervention Name: Rifaximin

Description: Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.

Arm Group Label: Antibiotic

Eligibility

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.

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

No

Overall Contact

Last Name: Meritxell Aguilo Garcia, MSc

Phone: +34935946024

Email: [email protected]

Location
Facility: Status: Contact: Investigator: Dr. Bofill Clinic Xavier Aldeguer Mante, MD [email protected] Xavier Aldeguer Mante, MD Principal Investigator
Location Countries

Spain

Verification Date

2020-11-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Probiotic

Type: Experimental

Description: Treatment with probiotic formula

Label: Antibiotic

Type: Other

Description: Treatment with antibiotic rifaximin

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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