Fecal Microbiota Therapy for Recurrent Clostridium Difficile Infection

• Status: Not yet recruiting
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Interventional, single arm, single-centre trial to evaluate the effectiveness and safety of fecal microbiota therapy (FMT) in the investigators population.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Queen Elizabeth II Health Sciences Centre
• Treatments: Antidiarrheals; Loperamide; Metronidazole; Vancomycin

Criteria

Inclusion Criteria:

1. Adults aged ≥ 18 yrs of age.

2. Recurrent CDI despite two courses of standard treatment (ie. 10 days of oral vancomycin or metronidazole) and a 6 week taper of oral vancomycin.

3. Laboratory confirmation of CDI by enzyme immunoassay (EIA), cytotoxicity assay and/or polymerase chain reaction (PCR).

4. Presence of persistent diarrhea defined as ≥ 3 loose or watery bowel movements in 24hr continuing for >2 days and diarrhea ongoing at the time of inclusion.

Exclusion Criteria:

1. Severely immunosuppressed patients will not be enrolled. This is defined as >20 mg prednisone/d for >1 month, recent transplant patients (haematological <2yrs and solid organ < 6 months), transplant with active graft versus host disease, HIV (with CD4<200), immunosuppressive antibody treatment (eg. tumour necrosis factor inhibitor, rituximab), other high dose long term systemic immunosuppression) and severe congenital immunodeficiency.

2. Age <18 years old.

3. Pregnancy.

4. Patient expected to expire in < 30d.

5. Current hospital admission for an indication other than CDI or need for vasopressor medication.