The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation
Condition: Clostridium Difficile Infection; C.Difficile Diarrhea; CDI
MeSH terms: Infections; Clostridium Infections; Diarrhea
Intervention: Low Dose FMT Capsule DE; Single Dose FMT Capsule DE; Placebo oral capsule
Intervention description: 5 FMT Capsule DE along with antibiotic; followed by five capsules FMT Capsule DE x 7 days post-antibiotic course.; 30 pill FMT Capsule DE treatment x 1, 48-72 hours following completion of antibiotic treatment.; Five capsules per day along with antibiotic; followed by five capsules per day for seven days post-antibiotic treatment.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This is a phase 2, double-blind, randomized, placebo-controlled trial assessing the effects of either daily (group 1) or one-time (group 2) oral FMT on the composition and function of gut microbiome compared to placebo (group 3) in a population of patients with a history of Clostridium difficile infection (CDI).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 1.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: FMT; Fecal Microbiota Transplant

Summary:

      The primary objective of this study is to compare the gut microbiota and clinical outcomes of
      oral FMT during antibiotic treatment, immediately following antibiotic treatment, and
      placebo. The second objective is to assess the safety and feasibility of daily oral Fecal
      Microbiome Transplant (FMT) as a treatment option.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Cognitively intact and willing to provide informed consent

          2. Willing and able to comply with all study procedures for the duration of the study

          3. Able to take oral medications

          4. Age 18 or over

          5. Recent CDI episode occurring in the last 180 days with completion of therapy as
             confirmed by the electronic medical record (EMR)

          6. Receiving antibiotics at enrollment for reasons other than CDI and having taken the
             antibiotics for no longer than 10 days.

          7. Women of childbearing potential in a sexual relationship with men must use an
             acceptable method of contraception (including, but not limited to, barriers with
             additional spermicidal foam or jelly, intrauterine devices, hormonal contraception
             started at least 30 days before enrollment into the study, or intercourse with men who
             underwent a vasectomy) for 4 weeks following completion of the study treatment,

          8. Males must agree to avoid impregnation of women during and for 4 weeks following
             completion of the study treatment.

          9. Able to take the test capsule successfully with no signs or symptoms of dysphagia.

        Exclusion Criteria:

          1. Females who are pregnant, lactating, or planning to become pregnant during the study.
             Female patients of childbearing potential will take a pregnancy test at the
             intervention visit and will be excluded if pregnant.

          2. Inability (e.g. dysphagia) to or unwilling to swallow capsules

          3. Known or suspected toxic megacolon and or known small bowel ileus

          4. Bowel obstruction or other gut motility issues occurring in the last two weeks taht
             are unresolved as noted by the patient or in the EMR

          5. Major gastrointestinal surgery (e.g. significant bowel resection) within 3 months
             before enrollment not including appendectomy or cholecystectomy.

          6. History of bariatric or colectomy surgery

          7. Concurrent intensive induction chemotherapy, radiation therapy, or biologic treatment
             for an active malignancy. Patients on maintenance chemotherapy may be enrolled after
             consultation with the medical monitor.

          8. Expected life expectancy less than 6 months.

          9. Patients with severe anaphylactic or anaphylactoid food allergy.

         10. Solid organ transplant recipients ≤90 days post-transplant or on active treatment for
             rejection

         11. Neutropenia (≤500 neutrophils/mL) or other severe immunosuppression. Anti-tumor
             necrosis factor (TNF) will be permitted. Patients on monoclonal antibodies to B and T
             cells, glucocorticoids, antimetabolites (azathioprine, 6-mercaptopurine,
             methotrexate), calcineurin inhibitors (tacrolimus, cyclosporine), and mycophenolate
             mofetil may only be enrolled after consultation with the medical monitor.

         12. At risk of CMV/EBV associated disease, negative immunoglobulin gamma (IgG) testing for
             cytomegalovirus (CMV) or Epstein Barr Virus (EBV)

         13. Any other gastrointestinal illness including diarrhea

         14. On oral vancomycin or metronidazole

         15. Having been taking the currently prescribed antibiotic for over 10 days

         16. Any condition that would jeopardize the safety or rights of the patient, would make it
             unlikely for the patient to complete the study, or would confound the results of the
             study.