Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Sponsor
AB Biotics, SA (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04316806
Collaborator
(none)
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of a Probiotic Formula in Reducing Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)
Actual Study Start Date :
Nov 20, 2020
Anticipated Primary Completion Date :
Apr 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Gut microbiota [0 and 4 weeks]

    Intestinal microbiota composition studied by metagenomics analysis from faecal samples

  2. 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)

  3. 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).

  4. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Dr. Bofill Clinic Girona Spain 17002

Sponsors and Collaborators

  • AB Biotics, SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
AB Biotics, SA
ClinicalTrials.gov Identifier:
NCT04316806
Other Study ID Numbers:
  • Probiotic_IBS+SIBO
First Posted:
Mar 20, 2020
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022