Clinical trial NCT03617445 (phase 2, status: suspended)
Conditions: clostridium difficile infection recurrence
ICD codes: A05.2, A04.71, A04.72, B96.7
Drugs: fmt oral capsule, oral vancomycin, fmt oral placebo, oral vancomycin placebo
SMILES: CN[C@H](CC(C)C)C(=O)N[C@@H]1[C@H](O)C2=CC=C(OC3=C(O[C@@H]4O[C@H](CO)[C@@H](O)[C@H](O)[C@H]4O[C@H]4C[C@](C)(N)[C@H](O)[C@H](C)O4)C4=CC(=C3)[C@@H](NC(=O)[C@H](CC(N)=O)NC1=O)C(=O)N[C@@H]1C3=CC(=C(O)C=C3)C3=C(O)C=C(O)C=C3[C@H](NC(=O)[C@@H](NC1=O)[C@H](O)C1=CC(Cl)=C(O4)C=C1)C(O)=O)C(Cl)=C2, CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O, CCCCCCCCCC(=O)N[C@@H](CC1=CNC2=C1C=CC=C2)C(=O)N[C@@H](CC(N)=O)C(=O)N[C@@H](CC(O)=O)C(=O)N[C@H]1[C@@H](C)OC(=O)[C@H](CC(=O)C2=C(N)C=CC=C2)NC(=O)[C@@H](NC(=O)[C@@H](CO)NC(=O)CNC(=O)[C@H](CC(O)=O)NC(=O)[C@@H](C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CCCN)NC(=O)CNC1=O)[C@H](C)CC(O)=O
Reason stopped: 
    suspended to accrual due to covid-19
  
Eligibility criteria:

        Inclusion Criteria:

          -  Is able to provide written informed consent

          -  Is willling to comply with all study procedures and be available for study duration

          -  Can take oral medication

          -  Is a solid organ transplant (SOT) recipient

          -  Has had at recurrent C. difficile infection defined as: positive C. difficile testing
             in stool and diarrhea (three or more loose stools over 24 hours) during the 180 day
             period following completion of treatment for prior episode.

          -  History of positive IgG test (patient or organ donor) to cytomegalovirus (CMV) and
             Epstein-Barr Virus (EBV)

          -  Negative urine or serum pregnancy test for women of childbearing potential and agree
             to use effective form of contraception until 6 weeks post treatment

          -  Clinical response to 4-7 days of oral antibiotic standard of care treatment for the
             current episode of CDI. Clinical response is defined as greater than or equal to 25%
             reduction of diarrhea.

        Exclusion Criteria:

          -  Active intestinal disease (e.g. Crohn's disease, ulcerative colitis)

          -  Major bowel resection surgery within 90 days of randomization

          -  Known or suspected toxic megacolon and/or small bowel ileus

          -  History of total colectomy or bariatric surgery

          -  Dysphagia; oropharyngeal, S), or patient has evidence of dysphagia when the 'safety
             test' capsule is administered.

          -  Neutropenia, ≤ 500 neutrophils/ml [noted in medical records and resulted within 30
             days of Visit 1]).

          -  Expected life expectancy is less than 6 months.

          -  Is taking concomitant antibiotics within 48 hours of Visit 2. Topical antibiotics,
             antibiotics - for transplant prophylaxis, and C. difficile antibiotic treatment
             antibiotics are permitted.

          -  Unwilling to withhold probiotics. Probiotics include supplements, prescriptions, and
             non-prescriptions. Foods (like yogurt) are not prohibited

          -  Concurrent intensive induction chemotherapy, radiation therapy or biological treatment
             for any active malignancy. Patients on maintenance chemotherapy could be enrolled
             after consultation with the study Medical Monitor.

          -  Any severe food allergy, defined as a history of anaphylaxis, systemic urticarial or
             angioedema attributed to a food and requiring current avoidance precautions.

          -  Gastroparesis.

          -  Symptomatic co-infection with another intestinal pathogen as determined by chart
             review.

          -  Women who are pregnant, lactating or planning on becoming pregnant during the study.

          -  Not suitable for study participation due to other reasons at the discretion of the
             investigators.