Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04316806
• Other study ID #: Probiotic_IBS+SIBO
• Status: Terminated
• Phase: N/A
• Start date: November 20, 2020
• Est. completion date: September 1, 2022

Study information

• Verified date: February 2022
• Source: AB Biotics, SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Small Intestinal Bacterial Overgrowth
• Syndrome

Intervention

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

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

Locations

Country	Name	City	State
Spain	Dr. Bofill Clinic	Girona

Sponsors (1)

Lead Sponsor	Collaborator
AB Biotics, SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SIBO	SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)	0 and 4 weeks
Secondary	Gut microbiota	Intestinal microbiota composition studied by metagenomics analysis from faecal samples	0 and 4 weeks
Secondary	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
Secondary	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
Secondary	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