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

NCT ID: NCT03353506

Last Updated: 2020-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-14
• Study Completion Date: 2019-10-10

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.

Conditions

Enterocolitis; Recurrent Clostridium Difficile Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

LFMT

Lyophilized fecal microbiota transplant capsules

Group Type: ACTIVE_COMPARATOR

LFMT

Intervention Type: BIOLOGICAL

Lyophilized fecal microbiota transplant

LSFF

Lyophilized sterile fecal filtrate capsules

Group Type: EXPERIMENTAL

LSFF

Intervention Type: BIOLOGICAL

Lyophilized sterile fecal filtrate

Interventions

LFMT

Lyophilized fecal microbiota transplant

Intervention Type: BIOLOGICAL

LSFF

Lyophilized sterile fecal filtrate

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. 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.

2. CDI under symptomatic control with 3 or fewer unformed stools in 24 hours for at least 2 consecutive days prior to treatment

3. Ability to provide informed consent.

4. Females and males must agree to use effective contraception for the duration of the study as applicable

Exclusion Criteria

1. 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.

2. Chronic diarrheal illness such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission of 3 months prior to enrollment.

3. Taking or planning to take an investigational drug within 3 months of enrollment.

4. Immunosuppression

5. Chemotherapy or radiation therapy

6. oropharyngeal or significant esophageal dysphagia

7. Ileus or small bowel obstruction

8. Subtotal colectomy

9. Pregnancy or planning to become pregnant within 3 months of enrollment

10. Breastfeeding or planning to breastfeed during the trial

11. Active infection requiring antibiotic therapy.

12. Life expectancy <6 months -

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Alberta

OTHER

Sponsor Role: collaborator

Dina Kao

OTHER

Sponsor Role: lead

Responsible Party

Dina Kao

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Dina Kao, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

Pro00076309

Identifier Type: -

Identifier Source: org_study_id