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)

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.

Study Overview

• Status: Terminated
• Conditions: Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth
• Intervention / Treatment: Dietary supplement: Probiotic; Drug: Rifaximin

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Girona, Spain, 17002
    • Dr. Bofill Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Probiotic; Treatment with probiotic formula	Dietary supplement: Probiotic; Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
Other: Antibiotic; Treatment with antibiotic rifaximin	Drug: Rifaximin; Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SIBO	SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)	0 and 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiota	Intestinal microbiota composition studied by metagenomics analysis from faecal samples	0 and 4 weeks
IBS severity	Measurement of IBS severity by Irritable Bowel Syndrome-Severity Score (IBSSS), ranging from 0 to 500 (<75, remission; 75-175, mild; 175-300, moderate; >300, severe cases)	0, 4 and 8 weeks
Intestinal related anxiety	Measurement of gastrointestinal specific anxiety by Visceral Sensitivity Index (VSI), 15 questions rated from 1 to 6. Higher ratings represent greater severity (min score= 15, max score= 90).	0, 4 and 8 weeks
Global improvement after treatment	Measured with on one question with 7 possible answers: (1) much worse, (2) moderately worse, (3) slightly worse, (4) unchanged, (5) slightly better, (6) moderately better, or (7) much better.	8 weeks

Collaborators and Investigators

• Sponsor: AB Biotics, SA

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2020
• Primary Completion (Actual): September 1, 2022
• Study Completion (Actual): September 1, 2022

Study Registration Dates

• First Submitted: March 3, 2020
• First Submitted That Met QC Criteria: March 19, 2020
• First Posted (Actual): March 20, 2020

Study Record Updates

• Last Update Posted (Actual): November 8, 2022
• Last Update Submitted That Met QC Criteria: November 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Anti-Infective Agents; Gastrointestinal Agents; Anti-Bacterial Agents; Rifaximin
• Other Study ID Numbers: Probiotic_IBS+SIBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No