Evaluating Diet Effects on Gut Microbiome to Prevent Recurrent Clostridioides Difficile Infection in Adults

What this Trial Is About

Researchers are evaluating how diet affects the gut microbiome in adults who have Clostridioides difficile infection CDI. This study focuses on preventing recurrent CDI by comparing different diets combined with health counseling. The trial is randomized and single-blinded to conceal diet details from participants until the study ends, to prevent bias in dietary intake. Participants will be randomly assigned to receive either an experimental diet or a control diet, both provided as prepared meals for two weeks. After this, participants are asked to continue a similar diet for an additional six weeks. Health counseling sessions will be conducted remotely by phone or video at least twice between weeks 2 and 8. The study includes a control group that will be informed about the tested diet only after study completion. During the study, participants will complete questionnaires and provide multiple stool samples to track changes in their gut microbiome diversity and quality of life related to CDI. The main outcome is the change in gut microbiome diversity measured by 16S rRNA sequencing from baseline to week 2. Secondary outcomes include microbiome changes at week 8, incidence of CDI recurrence, diet tolerability, and quality of life. The study duration is about eight weeks, with monitoring to understand how diet and health behaviors influence CDI recurrence risk.

Lifestyle and Recurrent Clostridioides Difficile Infection (CDI)