NCT04316806

Effect of a Probiotic Formula on Reducing SIBO in IBS Patients

Efficacy of a Probiotic Formula in Reducing Small Intestinal Bacterial Overgrowth (SIBO) in Patients With Irritable Bowel Syndrome (IBS)

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: AB Biotics, SA · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irritable Bowel Syndrome
• Small Intestinal Bacterial Overgrowth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic	Probiotic (dietary supplement) administrated once daily (u.i.d) for 8 weeks (3 billion cfus per day)
DRUG	Rifaximin	Antibiotic rifaximin consisting 400 mg capsules administrated twice daily (b.i.d) for 1week.

Timeline

• Start date: 2020-11-20
• Primary completion: 2022-09-01
• Completion: 2022-09-01
• First posted: 2020-03-20
• Last updated: 2022-11-08

Locations

1 site across 1 country: Spain