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. 2023 Apr 25;2023(4):CD013871. doi: 10.1002/14651858.CD013871.pub2

NCT02774382.

Study name Rectal bacteriotherapy, fecal microbiota transplantation or oral vancomycin treatment of recurrent Clostridium difficile infections
Methods Randomized controlled trial
Participants Inclusion criteria

  1. Age ≥ 18 years

  2. Verified recurrent CDI with symptoms of CDI and microbiologic verification (PCR)

  3. Previously treated for CDI with ≥ 10 days of vancomycin or metronidazole

  4. Able to read and understand Danish


Exclusion criteria

  1. Life expectancy < 3 months.

  2. Allergy toward vancomycin

  3. Other infection in the GI tract with clinical symptoms similar to CDI

  4. Other illness in the GI tract with clinical symptoms similar to CDI

  5. Use of antibiotics for > 14 days treating other infections

  6. Planning pregnancy, pregnant, or breastfeeding.

  7. Severe immune suppression which makes FMT/RBT relatively contraindicated
Interventions Intervention

  1. Vancomycin + FMT


Comparison

  1. Vancomycin

  2. Vancomycin + bacteriotherapy
Outcomes Primary outcomes

  1. Clinical cure of rCDI defined as participant‐reported absence of Clostridium difficile infection 90 days after treatment. The investigator will call the patient by telephone and fill out a digital questionnaire (time frame: 90 days)


Secondary outcomes

  1. Early (first 30 days after treatment) or late (180 days after treatment) recurrence of CDI after the end of treatment defined as recurrence of symptoms of CDI and a positive stool sample with C difficile (PCR) (time frame: 30 and 180 days after ended treatment)

  2. Days with diarrhea (time frame: 1, 4, 8 and 12 days after ended treatment)

  3. CDI‐associated hospital admission and hospital admission of other causes in the follow‐up period (time frame: 180 days after ended treatment)

  4. CDI‐associated hospital outpatient contact and hospital outpatient contact of other causes in the follow‐up period (time frame: 180 days after ended treatment)

  5. CDI‐associated mortality and all‐cause mortality (time frame: 30, 90 and 180 days after ended treatment)

  6. Numbers of patients with clinical cure (absence of C difficile infection) after study treatment divided into 2 groups depending on numbers of recurrences of CDI (time frame: 90 days after ended treatment)

  7. Effect of treatment depending on the CD strain, i.e. toxin B CDI cases, toxin B plus binary toxin CDI cases and CD027 CDI cases (time frame: 90 days after ended treatment)

  8. Effect of the treatment depending on the participant's serum‐level of antibodies towards toxin A and B at the time of inclusion (time frame: 90 days after ended treatment)

  9. Adverse effects in the 3 treatment arms (time frame: 14 days after ended treatment)

  10. Characterizations of the GI microbiota before and after treatment with FMT/RBT in conjunction with characterization of the donor's microbiota or the RBT bacterial mix (time frame: 180 days after ended treatment)

  11. Other antibiotic treatments associated with new recurrences of CDI (time frame: within 180 days after ended treatment)

  12. Evaluation of the composition of bile acids before and after treatment with FMT/RBT (time frame: 90 days after ended treatment)

  13. Characterization of the CD strains by whole genome sequencing (time frame: 90 days after ended treatment)

  14. Identification of age as a risk factor for treatment success/failure (time frame: 90 days after ended treatment)

  15. Identifying if Charlson comorbidity index is associated to treatment success/failure (time frame: 90 days after ended treatment)
Starting date 1 May 2017
Contact information Andreas M Petersen MD, Principal Investigator, Hvidovre University Hospital
Notes Estimated enrollment: 450
Status: unknown