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Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

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ClinicalTrials.gov Identifier: NCT03353506
Recruitment Status : Active, not recruiting
First Posted : November 27, 2017
Last Update Posted : March 26, 2019
Sponsor:
Collaborator:
University of Alberta
Information provided by (Responsible Party):
Dina Kao, University of Alberta

Brief Summary:

Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry.

Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).


Condition or disease Intervention/treatment Phase
Enterocolitis Recurrent Clostridium Difficile Infection Biological: LFMT Biological: LSFF Phase 2

Detailed Description:

This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules.

Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 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 capsules appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care
Primary Purpose: Treatment
Official Title: A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)
Actual Study Start Date : February 14, 2018
Estimated Primary Completion Date : January 15, 2021
Estimated Study Completion Date : January 15, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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

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




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


Secondary Outcome Measures :
  1. Resolution of RCDI [ Time Frame: 24 weeks ]
    Proportion of subjects 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 pain

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



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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:

  1. 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 toxin, each occurring within 3 months of each other.
  2. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
  3. Ability to provide informed consent.
  4. Females and males must agree to use effective contraception for the duration of the study as applicable

Exclusion Criteria:

  1. Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
  2. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
  3. Taking or planning to take an investigational drug within 3 months of enrollment.
  4. Immunosuppression
  5. Chemotherapy or radiation therapy
  6. oropharyngeal or significant esophageal dysphagia
  7. Ileus or small bowel obstruction
  8. Subtotal colectomy
  9. Pregnancy or planning to become pregnant within 3 months of enrollment
  10. Breastfeeding or planning to breastfeed during the trial
  11. Active infection requiring antibiotic therapy.
  12. 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): NCT03353506


Locations
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Canada, Alberta
University of Alberta
Edmonton, Alberta, Canada, T6G 2X8
Sponsors and Collaborators
Dina Kao
University of Alberta
Investigators
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Principal Investigator: Dina Kao, MD University of Alberta

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Responsible Party: Dina Kao, Medical Doctor, University of Alberta
ClinicalTrials.gov Identifier: NCT03353506     History of Changes
Other Study ID Numbers: Pro00076309
First Posted: November 27, 2017    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 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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Infection
Communicable Diseases
Clostridium Infections
Enterocolitis
Gram-Positive Bacterial Infections
Bacterial Infections
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases