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Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

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ClinicalTrials.gov Identifier: NCT03527056
Recruitment Status : Not yet recruiting
First Posted : May 16, 2018
Last Update Posted : May 16, 2018
Sponsor:
Collaborators:
OpenBiome
Finch Research and Development LLC.
Information provided by (Responsible Party):
Zachary A. Rubin, MD, University of California, Los Angeles

Brief Summary:
Carbapenem-Resistant Enterobacteriaceae (CRE) are bacteria that have become resistant to carbapenems by producing enzymes that break down carbapenems. The prevalence of CRE continues to rise globally but the treatment options are extremely limited. In case series, isolation of CRE from any site, whether there is clinical infection or not, has been associated with all-cause hospital mortality ranging from 29% to 52%. There are no known methods for reliably decolonizing gastrointestinal (GI) CRE. In rare case reports, fecal microbiota transplant (FMT) has successfully eradicated gastrointestinal colonization of CRE, but there has been no larger study further investigating this. FMT via oral capsules is the least invasive method and has demonstrated efficacy and short-term safety in treating patients with recurrent Clostridium difficile infections. Therefore, the investigators propose this pilot study to determine the effectiveness of oral capsule fecal transplantation in the decolonization of gastrointestinal CRE.

Condition or disease Intervention/treatment Phase
Enterobacteriaceae Infections Fecal Microbiota Transplantation Biological: Fecal Microbiota Transplantation Early Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Study Using Oral Capsule Fecal Microbiota Transplant To Decolonize Gastrointestinal Carbapenem-Resistant Enterobacteriaceae (CRE)
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: Oral capsule fecal transplantation
Enrolled patients who have screened positive for CRE in the stool will receive fecal transplant via OpenBiome oral capsules. The patient is given 90 minutes to swallow all capsules and does not require any anesthesia or sedation. Stool samples to test for CRE will be taken 10 days and 30 days after the fecal transplant.
Biological: Fecal Microbiota Transplantation
This is a parallel arm study. All participants in the experimental arm will receive a single fecal transplantation via oral capsules to determine effectiveness and safety in decolonizing gastrointestinal CRE.
Other Names:
  • FMT
  • Fecal Transplant

No Intervention: Observation
Enrolled patients who have screened positive for CRE in the stool will have stool samples to test for CRE taken 10 days and 30 days after initial enrollment.



Primary Outcome Measures :
  1. Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant [ Time Frame: 10 days ]
    CRE decolonization is defined by absence of CRE on stool culture using standard clinical laboratory techniques. Stool samples will be collected 10 days after FMT.

  2. Proportion of participants with an adverse event through day 10 (+/- 3 days) after FMT [ Time Frame: 10 days ]
    Telephone calls are made to participants 10 days after FMT to assess for adverse event, severe adverse event, and adverse events of special interest (newly acquired transmissible infectious diseases).


Secondary Outcome Measures :
  1. Proportion of participants with CRE decolonization at month 1 (+/-5 days) after FMT [ Time Frame: 1 month ]
    CRE decolonization is defined by absence of CRE on stool culture using standard clinical laboratory techniques. Stool samples will be collected 30 days after FMT.

  2. Proportion of participants with CRE infection at day 10 (+/-3 days) and month 1 (+/-5 days) after FMT [ Time Frame: 1 month ]
    CRE infection will be defined as an associated bacteremia, urinary tract infection, wound-related infection or other clinical infection deemed to be CRE associated at the discretion of the treating physician.

  3. Proportion of participants with an adverse event, severe adverse event, or adverse events of special interest through month 1 (+/-5 days) after FMT. [ Time Frame: 1 month ]
    Telephone calls are made to participants 1 month after FMT to assess for adverse event, severe adverse event, and adverse events of special interest (newly acquired transmissible infectious diseases).

  4. Proportion of participants with a severe adverse event at month 6 (+/-14 days) after FMT. [ Time Frame: 6 months ]
    Telephone calls are made to participants 6 months after FMT to assess for severe adverse event.

  5. Proportion of participants with microbial engraftment assessed by microbiome disruption index (MDI) (MDI-community and MDI-species) measured by 16s ribosomal RNA at time of enrollment, day 10 (+/-3 days) and month 1 (+/-5 days) after FMT [ Time Frame: 1 month ]
    Stool samples collected at baseline before FMT, day 10 after FMT, 1 month after FMT will be sent for 16s sequencing.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Outpatient
  • Have intestinal carriage of CRE

Exclusion Criteria:

  • Pregnant
  • Peripheral WBC >12 x 10^9/L and/or temperature >38 degrees Celsius
  • Swallowing dysfunction or known chronic aspiration
  • Delayed gastric emptying
  • History of intestinal obstruction
  • Active CRE infection
  • Acute exacerbation of underlying comorbid condition
  • Severely immunocompromised patients
  • Inflammatory bowel disease
  • Allergies to ingredients Generally Recognized as Safe
  • Adverse event attributable to previous FMT
  • Concomitant antibiotic use or antibiotic use 48 hours before FMT

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): NCT03527056


Contacts
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Contact: Lin Lisa, MD 310-206-0449 ldlin@mednet.ucla.edu

Sponsors and Collaborators
Zachary A. Rubin, MD
OpenBiome
Finch Research and Development LLC.
Investigators
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Principal Investigator: Zachary Rubin, MD University of California, Los Angeles

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Responsible Party: Zachary A. Rubin, MD, Medical Director of UCLA Clinical Epidemiology and Infection Prevention, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT03527056     History of Changes
Other Study ID Numbers: 16-001946
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: May 16, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zachary A. Rubin, MD, University of California, Los Angeles:
CRE
Additional relevant MeSH terms:
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Enterobacteriaceae Infections
Gram-Negative Bacterial Infections
Bacterial Infections