Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

University of California, Los Angeles (UCLA)

Status and phase: Withdrawn; Early Phase 1

Conditions: Enterobacteriaceae Infections; Fecal Microbiota Transplantation

Treatments: Biological: Fecal Microbiota Transplantation

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03527056

16-001946

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Oral capsule fecal transplantation

Experimental group

Description:

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.

Treatment:

Biological: Fecal Microbiota Transplantation

Observation

No Intervention group

Description:

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.