Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.

Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.

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 toxin, each occurring within 3 months of each other.
• CDI 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 use effective contraception for the duration of the study as applicable

Exclusion criteria

• Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
• Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
• Taking or planning to take an investigational drug within 3 months of enrollment.
• Immunosuppression
• Chemotherapy or radiation therapy
• oropharyngeal or significant esophageal dysphagia
• Ileus or small bowel obstruction
• Subtotal colectomy
• Pregnancy or planning to become pregnant within 3 months of enrollment
• Breastfeeding or planning to breastfeed during the trial
• Active infection requiring antibiotic therapy.
• Life expectancy <6 months -