Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.

Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.

Inclusion criteria

• at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
• CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
• Ability to provide informed consent
• Females and males must agree to effective contraception for the duration of the study

Exclusion criteria

• Severe or fulminant colitis
• Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
• Those taking or planning to take an investigational drug within 3 months of enrollment
• Chemotherapy or radiation therapy
• Oropharyngeal or significant esophageal dysphagia
• Ileus or small bowel obstruction
• Pregnant or planning to become pregnant within 3 months
• Breastfeeding or planning to breastfeed during the trial
• Active infection requiring antibiotics
• Life expectancy <6 months Those with history of total colectomy