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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 : Recruiting
First Posted : January 16, 2019
Last Update Posted : June 21, 2019
Sponsor:
Collaborators:
University of British Columbia
University of Calgary
Information provided by (Responsible Party):
University of Alberta

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.


Condition or disease Intervention/treatment Phase
Clostridia Difficile Colitis Clostridium Difficile Diarrhea Biological: Lyophilized fecal microbiota transplant Biological: Lyophilized sterile fecal filtrate Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 110 participants
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
Official Title: 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)
Actual Study Start Date : March 21, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: LFMT
Lyophilized fecal microbiota transplant capsules
Biological: Lyophilized fecal microbiota transplant
15 capsules

Experimental: LSFF
Lyophilized sterile fecal filtrate capsules
Biological: Lyophilized sterile fecal filtrate
15 capsules




Primary Outcome Measures :
  1. Resolution of RCDI [ Time Frame: 8 weeks ]
    Proportion of patients without RCDI


Secondary Outcome Measures :
  1. Resolution of RCDI [ Time Frame: 24 weeks ]
    Proportion of patients with sustained cure

  2. Serious Adverse Events [ Time Frame: 8 weeks ]
    Mortality directly attributable to CDI or treatment

  3. Serious Adverse Events [ Time Frame: 8 weeks ]
    Infection directly attributable to treatment

  4. Minor Adverse Events [ Time Frame: 1 week ]
    Nausea

  5. Minor Adverse Events [ Time Frame: 1 week ]
    Vomiting

  6. Minor Adverse Events [ Time Frame: 1 week ]
    Abdominal discomfort

  7. Difficulty swallowing capsules [ Time Frame: 1 week ]
    Reported by patients as ranging between none, moderate or severe

  8. Fever [ Time Frame: 1 week ]
    Temperature of >37.8C



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03806803


Contacts
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Contact: Dina Kao, MD 780 492 8307 dkao@ualberta.ca

Locations
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Canada, Alberta
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2X8
Contact: Dina Kao, MD    780 492 8307    dkao@ualberta.ca   
Sponsors and Collaborators
University of Alberta
University of British Columbia
University of Calgary
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta

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Responsible Party: University of Alberta
ClinicalTrials.gov Identifier: NCT03806803     History of Changes
Other Study ID Numbers: Pro00087406
First Posted: January 16, 2019    Key Record Dates
Last Update Posted: June 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Clostridium Infections
Diarrhea
Signs and Symptoms, Digestive
Signs and Symptoms
Gram-Positive Bacterial Infections
Bacterial Infections