NCT04074421

Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With IBS-D

Effects of Continuous Treatment With Rifaximin and Probiotics on the Gut Microbiota of Patients With Diarrhoea-predominant Irritable Bowel syndrome-a Multicentre Controlled Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

We will use the latest Rome IV criteria to recruit IBS-D patients and evaluate the effects of repeated treatment with rifaximin and sequential treatment with rifaximin and probiotics on different symptoms and quality of life. High-throughput sequencing combined with real-time quantitative PCR will be used to comprehensively analyze the effects of different drugs on intestinal flora. The study has important guiding significance for the treatment of patients with IBS-D.

Detailed description

According to the Rome IV diagnostic criteria, 200 patients with with diarrhoea-predominant irritable bowel syndrome (IBS-D) from the multi-center (8 units in the country) will be enrolled. The IBS Severity Inventory (IBS-SSS) and IBS Quality of Life Scores (QOL) will be used to evaluate the effect of treatments. Retreatment patients who are initially treated and not satisfied with the improvement of symptoms and quality of life will be treated with Rifaximin for 2 weeks. Fecal specimens will be collected from patients who responded to treatment, and the fecal bacteria will be analyzed by real-time polymerase chain reaction (PCR) using 16 S ribosomal ribonucleic acid (rRNA) gene. Patients who responded to Rifaximin treatment will be randomized into A (Probiotics group) and B (Placebo group). IBS symptom grade score and quality of life score will be evaluated before and after treatment, and fecal specimens of the responding patients will be collected for intestinal probiotics and harmful bacteria detection.

Conditions

• IBS - Irritable Bowel Syndrome
• Gut Microbiota

Interventions

Type	Name	Description
DRUG	Rifaximin	A non-aminoglycoside intestinal antibiotic, 400mg, twice one day for 2 weeks.
DRUG	Probiotic Formula	A probiotic called Enterococcus faecium, 500mg, triple one day for 4 weeks.
DRUG	Placebo oral tablet	Placebo oral tablet that has no therapeutic effect

Timeline

• Start date: 2020-05-10
• Primary completion: 2022-06-01
• Completion: 2022-12-01
• First posted: 2019-08-30
• Last updated: 2020-07-28

Locations

1 site across 1 country: China