Effect of a Probiotic Formula on Reducing SIBO in IBS Patients
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|ClinicalTrials.gov Identifier: NCT04316806|
Recruitment Status : Not yet recruiting
First Posted : March 20, 2020
Last Update Posted : March 20, 2020
|Condition or disease||Intervention/treatment||Phase|
|Irritable Bowel Syndrome Small Intestinal Bacterial Overgrowth||Dietary Supplement: Probiotic Drug: Rifaximin||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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|
Treatment with probiotic formula
Dietary Supplement: Probiotic
Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
Treatment with antibiotic rifaximin
Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.
- 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)
- Gut microbiota [ Time Frame: 0 and 4 weeks ]Intestinal microbiota composition studied by metagenomics analysis from faecal samples
- 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)
- 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).
- 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.
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
|Contact: Meritxell Aguilo Garcia, MScemail@example.com|
|Contact: Ariana Salavert Larrosa, PhDfirstname.lastname@example.org|
|Dr. Bofill Clinic|
|Girona, Spain, 17002|
|Principal Investigator: Xavier Aldeguer - Gastroenterology Chief, Dr|