Pilot Study Using Oral Capsule Fecal Microbiota Transplant To Decolonize Gastrointestinal Carbapenem-Resistant Enterobacteriaceae (CRE)

Pilot Study Using Oral Capsule FMT to Decolonize GI CRE



Sponsors


Source

University of California, Los Angeles

Oversight Info

Has Dmc

No

Is Fda Regulated Drug

Yes

Is Fda Regulated Device

No


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.

Overall Status

Not yet recruiting

Start Date

2018-09-01

Completion Date

2019-07-01

Primary Completion Date

2019-07-01

Phase

Early Phase 1

Study Type

Interventional

Primary Outcome

Measure

Time Frame

Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant
10 days
Proportion of participants with an adverse event through day 10 (+/- 3 days) after FMT
10 days

Secondary Outcome

Measure

Time Frame

Proportion of participants with CRE decolonization at month 1 (+/-5 days) after FMT
1 month
Proportion of participants with CRE infection at day 10 (+/-3 days) and month 1 (+/-5 days) after FMT
1 month
Proportion of participants with an adverse event, severe adverse event, or adverse events of special interest through month 1 (+/-5 days) after FMT.
1 month
Proportion of participants with a severe adverse event at month 6 (+/-14 days) after FMT.
6 months
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
1 month

Enrollment

20

Conditions


Intervention

Intervention Type

Biological

Intervention Name


Description

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.

Arm Group Label

Oral capsule fecal transplantation

Other Name

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

Gender

All

Minimum Age

18 Years

Maximum Age

N/A

Healthy Volunteers

Accepts Healthy Volunteers


Overall Official

Last Name

Role

Affiliation

Zachary Rubin, MD
Principal Investigator
University of California, Los Angeles

Overall Contact

Last Name

Lin Lisa, MD

Phone

310-206-0449

Email



Verification Date

2018-05-01

Lastchanged Date

N/A

Firstreceived Date

N/A

Responsible Party

Responsible Party Type

Sponsor-Investigator

Investigator Affiliation

University of California, Los Angeles

Investigator Full Name

Zachary A. Rubin, MD

Investigator Title

Medical Director of UCLA Clinical Epidemiology and Infection Prevention


Keyword

 CRE

Has Expanded Access

No

Condition Browse


Number Of Arms

2

Arm Group

Arm Group Label

Oral capsule fecal transplantation

Arm Group Type

Experimental

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.


Arm Group Label

Observation

Arm Group Type

No Intervention

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.



Firstreceived Results Date

N/A

Patient Data

Sharing Ipd

No


Firstreceived Results Disposition Date

N/A

Study Design Info

Allocation

Non-Randomized

Intervention Model

Parallel Assignment

Primary Purpose

Treatment

Masking

None (Open Label)


Study First Submitted

May 4, 2018

Study First Submitted Qc

May 4, 2018

Study First Posted

May 16, 2018

Last Update Submitted

May 4, 2018

Last Update Submitted Qc

May 4, 2018

Last Update Posted

May 16, 2018


ClinicalTrials.gov processed this data on May 16, 2018

Conditions

Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov, conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions

Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied. Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase

Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions that study is seeking to answer:

In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.

In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.

In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.

In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.

These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.



© 2018 ICH GCP