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Introduction

Clostridium difficile infection (CDI) is the most common cause of antibiotic-associated diarrhea. Recurrent CDI (rCDI) leads to severe morbidity, mortality and high costs. The most important mechanism for rCDI is a disturbed gut microbiota. Fecal Microbiota Transplantation (FMT) is a highly effective, but more expensive, method to prevent rCDI.

 

Objective

To build a prediction model for recurrent CDI, based on the gut microbiota composition and diversity, in combination with clinical characteristics, on the day of diagnosis of the first episode of CDI, and on changes in microbiota after 4-6 days of treatment.

The prediction model will help clinicians to stratify patients based on their recurrence risk to identify patients that benefit from treatment with FMT.

 

Hypothesis

A pilot analysis of the microbiota diversity and richness on the day of diagnosis in patients with CDI showed a decrease in diversity of Firmicutes in patients who developed rCDI (n=7), compared to CDI patients who did not develop rCDI (n=14). This suggests that the diversity of the gut microbiota on the day of diagnosis could help to identify patients at risk for rCDI.

 

Study design

A multicenter, prospective, observational study.

 

Study population

Inclusion: adult patients diagnosed with a primary episode of CDI.

Exclusion: proven infectious colitis during the last month, patients diagnosed with inflammatory bowel disease or celiac disease.

 

Intervention

Eligible patients will be asked to collect two fecal samples: one on the day of CDI diagnosis, and one on day 4-6 after the start of CDI treatment. In total, 150 patients with primary CDI will be included. In addition, data on patient characteristics, disease severity, C. difficile ribotype, CDI treatment, and use of medication will be collected.

The (change in) gut microbiota composition and diversity, and clinical characteristics of patients with primary CDI who developed rCDI will be compared with that of CDI patients who did not develop rCDI.

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