Back to resultsEffect of a Probiotic Formula on Reducing SIBO in IBS Patients
Primary Purpose
Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Probiotic
Rifaximin
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome
Eligibility 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.
Sites / Locations
- Dr. Bofill Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Probiotic
Antibiotic
Arm Description
Treatment with probiotic formula
Treatment with antibiotic rifaximin
Outcomes
Primary Outcome Measures
SIBO
SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)
Secondary Outcome Measures
Gut microbiota
Intestinal microbiota composition studied by metagenomics analysis from faecal samples
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)
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).
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04316806
Brief Title
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
Official Title
Efficacy of a Probiotic Formula in Reducing Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Why Stopped
Principal Investigator changed his job
Study Start Date
November 20, 2020 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
September 1, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AB Biotics, SA
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome, Small Intestinal Bacterial Overgrowth
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Probiotic
Arm Type
Experimental
Arm Description
Treatment with probiotic formula
Arm Title
Antibiotic
Arm Type
Other
Arm Description
Treatment with antibiotic rifaximin
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic
Intervention Description
Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Description
Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.
Primary Outcome Measure Information:
Title
SIBO
Description
SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)
Time Frame
0 and 4 weeks
Secondary Outcome Measure Information:
Title
Gut microbiota
Description
Intestinal microbiota composition studied by metagenomics analysis from faecal samples
Time Frame
0 and 4 weeks
Title
IBS severity
Description
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)
Time Frame
0, 4 and 8 weeks
Title
Intestinal related anxiety
Description
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).
Time Frame
0, 4 and 8 weeks
Title
Global improvement after treatment
Description
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.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
Dr. Bofill Clinic
City
Girona
ZIP/Postal Code
17002
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
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