Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Not Applicable

Terminated

• Conditions: Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth
• Interventions: Drug: Rifaximin; Dietary Supplement: Probiotic

• Registration Number: NCT04316806
• Lead Sponsor: 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.

Study Timeline

• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-19
• Study First Posted: 2020-03-20
• Study Start: 2020-11-20
• Status Verified: 2022-02
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01
• Last Update Submitted: 2022-11-02
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 8

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Antibiotic	Rifaximin	Treatment with antibiotic rifaximin
Probiotic	Probiotic	Treatment with probiotic formula

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Global improvement after treatment	8 weeks	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.
Gut microbiota	0 and 4 weeks	Intestinal microbiota composition studied by metagenomics analysis from faecal samples
IBS severity	0, 4 and 8 weeks	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)
Intestinal related anxiety	0, 4 and 8 weeks	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).

Trial Locations

Locations (1)

Dr. Bofill Clinic; 🇪🇸 Girona, Spain