Table 1

Enrolment eligibility

Inclusion criteria

  • Age 18 years and above, all gender

  • Diarrhoea*

  • Stool positive for tcdB (toxin B)

  • Non-severe or severe uncomplicated CDI

  • Within 120 hours of receiving standard therapy

  • Ability to comply with study procedures for the length of the study

Exclusion criteria

  • At enrolment, presence of any of the following:

    • Hypotension or shock

    • Megacolon or moderate to severe ileus

    • Acute abdomen

    • Admission to intensive care unit

  • Inability to tolerate oral or enteral medication

  • Presence of other known infectious aetiology of diarrhoea

  • COVID-19 coinfection at the time of CDI diagnosis

  • Absolute neutrophil count<500 mcL

  • Within 100 days of haematologic or solid organ transplant

  • Uncontrolled inflammatory bowel disease (eg, Crohn’s disease and ulcerative colitis) or other aetiology of non-infectious diarrhoea

  • Enrolment in another investigational drug trial

  • Current use of alternative treatment for CDI (eg, antibiotics other than metronidazole, vancomycin or fidaxomicin; IVIg; faecal transplant)

  • On probiotics and not willing to discontinue

  • Cirrhosis or in participants with ALT (alanine aminotransferase) >3X normal

  • End stage renal disease, not on dialysis or creatinine clearance or estimated GFR (glomerular filtration rate) of <30 mL/min even after adequate hydration

  • Life expectancy of <6 months

  • *Diarrhoea is defined as liquid stool or stool that takes the shape of the receptacle, with bowel movements occurring>3X within a 24 hour period.

  • ALT, alanin aminotransferase; CDI, Clostridioides difficile infection; GFR, glomerular filtration rate; tcdB, toxin B.