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Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04316806
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth Dietary Supplement: Probiotic Drug: Rifaximin Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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)
Estimated Study Start Date : May 2, 2020
Estimated Primary Completion Date : October 1, 2021
Estimated Study Completion Date : October 1, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

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)

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




Primary Outcome Measures :
  1. SIBO [ Time Frame: 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 [ Time Frame: 0 and 4 weeks ]
    Intestinal microbiota composition studied by metagenomics analysis from faecal samples

  2. IBS severity [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04316806


Contacts
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Contact: Meritxell Aguilo Garcia, MSc +34935946024 aguilo@ab-biotics.com
Contact: Ariana Salavert Larrosa, PhD +34935946024 salavert@ab-biotics.com

Locations
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Spain
Dr. Bofill Clinic
Girona, Spain, 17002
Principal Investigator: Xavier Aldeguer - Gastroenterology Chief, Dr         
Sponsors and Collaborators
AB Biotics, SA

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Responsible Party: AB Biotics, SA
ClinicalTrials.gov Identifier: NCT04316806    
Other Study ID Numbers: Probiotic_IBS+SIBO
First Posted: March 20, 2020    Key Record Dates
Last Update Posted: March 20, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Disease
Pathologic Processes
Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Anti-Bacterial Agents
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents