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Enterobacteriaceae InfectionsEarly Phase 1NCT03527056

Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

A Early Phase 1 study testing Fecal Microbiota Transplantation in people with Enterobacteriaceae Infections and Fecal Microbiota Transplantation, run by University of California, Los Angeles.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Fecal Microbiota Transplantation
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
Jun 2019to 24 Sep 2019
Phase
Early Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Outpatient
  • Have intestinal carriage of CRE

Who cannot join

  • 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
Show all 12Show fewer
  • 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

About this study

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

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.

Being tested
Fecal Microbiota Transplantation
Keywords
CRE
Medical subject headings
Enterobacteriaceae Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Fecal Microbiota TransplantationBiological

    Also called FMT, Fecal Transplant

    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.

Study groups in NCT03527056
Study groupRoleWhat they receive
Oral capsule fecal transplantationExperimentalEnrolled 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.
Receives: Biological: Fecal Microbiota Transplantation
ObservationNo interventionEnrolled 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant

    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.

    Measured: 10 days

  2. Proportion of participants with an adverse event through day 10 (+/- 3 days) after FMT

    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).

    Measured: 10 days

Secondary outcomes (5)

  1. Proportion of participants with CRE decolonization at month 1 (+/-5 days) after FMT

    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.

    Measured: 1 month

  2. Proportion of participants with CRE infection at day 10 (+/-3 days) and month 1 (+/-5 days) after FMT

    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.

    Measured: 1 month

  3. Proportion of participants with an adverse event, severe adverse event, or adverse events of special interest through month 1 (+/-5 days) after FMT.

    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).

    Measured: 1 month

  4. Proportion of participants with a severe adverse event at month 6 (+/-14 days) after FMT.

    Telephone calls are made to participants 6 months after FMT to assess for severe adverse event.

    Measured: 6 months

  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

    Stool samples collected at baseline before FMT, day 10 after FMT, 1 month after FMT will be sent for 16s sequencing.

    Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2018
  2. Study startJun 2019 (estimated)
  3. Primary completion24 Sep 2019
  4. Study completion24 Sep 2019

Why it stopped: Investigator left the institution

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03527056
Sponsor's protocol ID
16-001946
Status last verified
Oct 2019
First submitted
4 May 2018
Last updated
23 Oct 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Fecal Microbiota Transplantation in people with Enterobacteriaceae Infections and Fecal Microbiota Transplantation, run by University of California, Los Angeles.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of participants with CRE decolonization at day 10 (+/- 3 days) after fecal transplant (time frame: 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03527056.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2019.

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