Clinical trial NCT03527056: Pilot Study Using Oral Capsule FMT to Decolonize GI CRE
Official title: Pilot Study Using Oral Capsule Fecal Microbiota Transplant To Decolonize Gastrointestinal Carbapenem-Resistant Enterobacteriaceae (CRE)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Enterobacteriaceae Infections
Fecal Microbiota Transplantation
Keywords: CRE
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: OpenBiome
name: Finch Research and Development LLC.
First posted: 2018-05-16
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant
timeFrame: 10 days
measure: Proportion of participants with an adverse event through day 10 (+/- 3 days) after FMT
timeFrame: 10 days
Secondary outcomes:
measure: Proportion of participants with CRE decolonization at month 1 (+/-5 days) after FMT
timeFrame: 1 month
measure: Proportion of participants with CRE infection at day 10 (+/-3 days) and month 1 (+/-5 days) after FMT
timeFrame: 1 month
measure: Proportion of participants with an adverse event, severe adverse event, or adverse events of special interest through month 1 (+/-5 days) after FMT.
timeFrame: 1 month
measure: Proportion of participants with a severe adverse event at month 6 (+/-14 days) after FMT.
timeFrame: 6 months
measure: 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
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of California, Los Angeles
name: Zachary Rubin, MD
role: PRINCIPAL_INVESTIGATOR
References: