An interventional study of Probiotic and Rifaximin in Irritable Bowel Syndrome and Small Intestinal Bacterial Overgrowth, sponsored by AB Biotics, SA. Terminated at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-11-08.
Sponsored by AB Biotics, SA · Not applicable, Interventional, and Treatment
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.
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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's enrollment of 8 is below the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →AB Biotics, SA is the lead sponsor of 25 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients taking set doses of Proton Pump Inhibitors (PPIs) or antispasmodics can be included.
Exclusion Criteria:
Treatment with probiotic formula
Dietary Supplement: Probiotic
Treatment with antibiotic rifaximin
Drug: Rifaximin
Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.
SIBO
SIBO evolution determined by changes in exhaled H2 and methane (CH4) levels after ingestion of lactulose (25 g)
Time frame: 0 and 4 weeks
Gut microbiota
Intestinal microbiota composition studied by metagenomics analysis from faecal samples
Time frame: 0 and 4 weeks
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)
Time frame: 0, 4 and 8 weeks
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).
Time frame: 0, 4 and 8 weeks
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.
Time frame: 8 weeks
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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