Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

NCT04316806 | Terminated

• 1 other identifier: Probiotic_IBS+SIBO
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Irritable Bowel Syndrome; Small Intestinal Bacterial Overgrowth

Outcome Measures

Primary Outcomes (1)

• SIBO

  SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)

  0 and 4 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Probiotic

EXPERIMENTAL

Treatment with probiotic formula

Dietary Supplement: Probiotic

Antibiotic

OTHER

Treatment with antibiotic rifaximin

Drug: Rifaximin

Interventions

Probiotic DIETARY_SUPPLEMENT

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

Probiotic

Rifaximin DRUG

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

Antibiotic

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AB Biotics, SA: lead

Study Sites (1)

Dr. Bofill Clinic

Girona, 17002, Spain

Location

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Probiotics; Rifaximin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Rifamycins; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Lactams, Macrocyclic; Macrocyclic Compounds; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 20, 2020
• Study Start: November 20, 2020
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)