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Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

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ClinicalTrials.gov Identifier: NCT03806803
Recruitment Status : Not yet recruiting
First Posted : January 16, 2019
Last Update Posted : January 16, 2019
Sponsor:
Collaborators:
University of British Columbia
University of Calgary
Information provided by (Responsible Party):
University of Alberta

Tracking Information
First Submitted Date  ICMJE January 14, 2019
First Posted Date  ICMJE January 16, 2019
Last Update Posted Date January 16, 2019
Estimated Study Start Date  ICMJE March 2019
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
Resolution of RCDI [ Time Frame: 8 weeks ]
Proportion of patients without RCDI
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 14, 2019)
  • Resolution of RCDI [ Time Frame: 24 weeks ]
    Proportion of patients with sustained cure
  • Serious Adverse Events [ Time Frame: 8 weeks ]
    Mortality directly attributable to CDI or treatment
  • Serious Adverse Events [ Time Frame: 8 weeks ]
    Infection directly attributable to treatment
  • Minor Adverse Events [ Time Frame: 1 week ]
    Nausea
  • Minor Adverse Events [ Time Frame: 1 week ]
    Vomiting
  • Minor Adverse Events [ Time Frame: 1 week ]
    Abdominal discomfort
  • Difficulty swallowing capsules [ Time Frame: 1 week ]
    Reported by patients as ranging between none, moderate or severe
  • Fever [ Time Frame: 1 week ]
    Temperature of >37.8C
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection
Official Title  ICMJE A Multicenter Double Blind Randomized Study Comparing the Efficacy of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplantation (FMT) in the Management of Recurrent Clostridioides Difficile Infection (CDI)
Brief Summary

Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works.

Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups.

Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.

Detailed Description

This prospective double blind randomized study will enroll 110 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules.

Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
double blind randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
LFMT and LSFF appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care.
Primary Purpose: Treatment
Condition  ICMJE
  • Clostridia Difficile Colitis
  • Clostridium Difficile Diarrhea
Intervention  ICMJE
  • Biological: Lyophilized fecal microbiota transplant
    15 capsules
  • Biological: Lyophilized sterile fecal filtrate
    15 capsules
Study Arms  ICMJE
  • Active Comparator: LFMT
    Lyophilized fecal microbiota transplant capsules
    Intervention: Biological: Lyophilized fecal microbiota transplant
  • Experimental: LSFF
    Lyophilized sterile fecal filtrate capsules
    Intervention: Biological: Lyophilized sterile fecal filtrate
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: January 14, 2019)
110
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2023
Estimated Primary Completion Date March 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • at least 3 episodes of recurrent CDI with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile test, each occurring within 3 months of each other.
  • CDI infection under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
  • Ability to provide informed consent
  • Females and males must agree to effective contraception for the duration of the study

Exclusion Criteria:

  • Severe or fulminant colitis
  • Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
  • Chemotherapy or radiation therapy
  • Oropharyngeal or significant esophageal dysphagia
  • Ileus or small bowel obstruction
  • Pregnant or planning to become pregnant within 3 months
  • Breastfeeding or planning to breastfeed during the trial
  • Active infection requiring antibiotics
  • Life expectancy <6 months
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Dina Kao, MD 780 492 8307 dkao@ualberta.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03806803
Other Study ID Numbers  ICMJE Pro00087406
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE
  • University of British Columbia
  • University of Calgary
Investigators  ICMJE
Principal Investigator: Dina Kao, MD University of Alberta
PRS Account University of Alberta
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP