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Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

Primary Purpose

Enterocolitis, Recurrent Clostridium Difficile Infection

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

LFMT

LSFF

About this trial

This is an interventional treatment trial for Enterocolitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other.
CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment
Ability to provide informed consent.
Females and males must agree to use effective contraception for the duration of the study as applicable

Exclusion Criteria:

Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care.
Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.
Taking or planning to take an investigational drug within 3 months of enrollment.
Immunosuppression
Chemotherapy or radiation therapy
oropharyngeal or significant esophageal dysphagia
Ileus or small bowel obstruction
Subtotal colectomy
Pregnancy or planning to become pregnant within 3 months of enrollment
Breastfeeding or planning to breastfeed during the trial
Active infection requiring antibiotic therapy.
Life expectancy <6 months -

Sites / Locations

University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

LFMT

LSFF

Arm Description

Lyophilized fecal microbiota transplant capsules

Lyophilized sterile fecal filtrate capsules

Outcomes

Primary Outcome Measures

Resolution of RCDI

Proportion of subjects without RCDI

Secondary Outcome Measures

Resolution of RCDI

Proportion of subjects with sustained cure

Serious Adverse Events

Mortality directly attributable to CDI or treatment

Serious Adverse Events

Infection directly attributable to treatment

Minor Adverse Events

nausea

Minor Adverse Events

vomiting

Minor Adverse Events

abdominal pain

Difficulty in swallowing capsules

Reported by subjects as ranging between none, moderate or severe

Full Information

NCT ID

NCT03353506

First Posted

November 6, 2017

Last Updated

February 19, 2020

Sponsor

Dina Kao

Collaborators

University of Alberta

1. Study Identification

Unique Protocol Identification Number

NCT03353506

Brief Title

Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

Official Title

A Prospective Double Blind Randomized Pilot Study Comparing the Efficacy of Lyophilized Fecal Microbiota Transplantation (FMT) to Lyophilized Sterile Fecal Filtrate in the Management of Recurrent Clostridium Difficile Infection (CDI)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Completed

Study Start Date

February 14, 2018 (Actual)

Primary Completion Date

June 5, 2019 (Actual)

Study Completion Date

October 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Dina Kao

Collaborators

University of Alberta

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Fecal microbiota transplantation (FMT) for the treatment of recurrent Clostridium difficile infection (RCDI) has traditionally been offered as fecal slurry administered by enema, nasogastric tube or endoscopy. Frozen oral capsules have also shown efficacy. The potential advantage of lyophilized FMT is the relative ease of manufacturing and storage compared with fecal slurry. Sterile fecal filtrate has previously been shown to prevent Clostridium difficile infection (CDI) recurrence, suggesting that live bacteria may not be needed. This study will compare lyophilized sterile fecal filtrate (LSFF) with lyophilized FMT (LFMT) in the treatment of recurrent Clostridium difficile infection (RCDI).

Detailed Description

This prospective double blind randomized pilot study will enroll 40 subjects with recurrent Clostridium difficile infection in a 1:1 ratio to receive either LSFF or LFMT by capsules. Subjects will receive 15 capsules at week 0 and be assessed at Weeks 1, 4, 12 and 24. If treatment fails, subjects will be given open label LFMT from the same donor. If treatment fails again, another FMT will be offered and the form and route of FMT delivery will be at the discretion of the treating physician.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Enterocolitis, Recurrent Clostridium Difficile Infection

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Model Description

double blind randomized

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

LFMT and LSFF capsules appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care

Allocation

Randomized

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

LFMT

Arm Type

Active Comparator

Arm Description

Lyophilized fecal microbiota transplant capsules

Arm Title

LSFF

Arm Type

Experimental

Arm Description

Lyophilized sterile fecal filtrate capsules

Intervention Type

Biological

Intervention Name(s)

LFMT

Intervention Description

Lyophilized fecal microbiota transplant

Intervention Type

Biological

Intervention Name(s)

LSFF

Intervention Description

Lyophilized sterile fecal filtrate

Primary Outcome Measure Information:

Title

Resolution of RCDI

Description

Proportion of subjects without RCDI

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Resolution of RCDI

Description

Proportion of subjects with sustained cure

Time Frame

24 weeks

Title

Serious Adverse Events

Description

Mortality directly attributable to CDI or treatment

Time Frame

8 weeks

Title

Serious Adverse Events

Description

Infection directly attributable to treatment

Time Frame

8 weeks

Title

Minor Adverse Events

Description

nausea

Time Frame

1 week

Title

Minor Adverse Events

Description

vomiting

Time Frame

1 week

Title

Minor Adverse Events

Description

abdominal pain

Time Frame

1 week

Title

Difficulty in swallowing capsules

Description

Reported by subjects as ranging between none, moderate or severe

Time Frame

1 week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: at least 3 episodes of recurrent CDI, with each episode defined as 3 or more unformed stools in 24 hours associated with positive Clostridium difficile toxin, each occurring within 3 months of each other. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment Ability to provide informed consent. Females and males must agree to use effective contraception for the duration of the study as applicable Exclusion Criteria: Complicated CDI defined as WBC >35, significant abdominal pain and distention, evidence of toxin megacolon or pseudomembraneous colitis, hypotension defined as systolic blood pressure <90 mmHg unresponsive to fluid resuscitation, end organ failure, or requiring admission to intensive care. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment. Taking or planning to take an investigational drug within 3 months of enrollment. Immunosuppression Chemotherapy or radiation therapy oropharyngeal or significant esophageal dysphagia Ileus or small bowel obstruction Subtotal colectomy Pregnancy or planning to become pregnant within 3 months of enrollment Breastfeeding or planning to breastfeed during the trial Active infection requiring antibiotic therapy. Life expectancy <6 months -

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Dina Kao, MD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G2X8

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

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Lyophilized Fecal Transplant vs Lyophilized Fecal Filtrate in Recurrent C Diff Infection

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