Pilot Study Using Oral Capsule FMT to Decolonize GI CRE

Fecal Microbiota Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03527056
• Other study ID #: 16-001946
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: June 2019
• Est. completion date: September 24, 2019

Study information

• Verified date: October 2019
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 24, 2019
• Est. primary completion date: September 24, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Enterobacteriaceae Infections
• Fecal Microbiota Transplantation

Intervention

Biological:
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
University of California, Los Angeles	Finch Research and Development LLC., OpenBiome

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	10 days
Primary	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).	10 days
Secondary	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.	1 month
Secondary	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.	1 month
Secondary	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).	1 month
Secondary	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.	6 months
Secondary	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.	1 month