The GRAFT Study: Gut RecolonizAtion by Fecal Transplantation

• Status: Completed
• Trial end date: 2020-02-27
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Collaborator: Agency for Healthcare Research and Quality (AHRQ)
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular

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.