Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

NCT ID: NCT03527056

Last Updated: 2019-10-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: EARLY_PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-30
• Study Completion Date: 2019-09-24

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.

Conditions

Enterobacteriaceae Infections; Fecal Microbiota Transplantation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Fecal Microbiota Transplantation

Intervention Type: BIOLOGICAL

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BIOLOGICAL

Other Intervention Names

FMT; Fecal Transplant

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

OpenBiome

INDUSTRY

Sponsor Role: collaborator

Finch Research and Development LLC.

INDUSTRY

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zachary Rubin, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Los Angeles

Other Identifiers

16-001946

Identifier Type: -

Identifier Source: org_study_id