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

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)

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).

Study Overview

• Status: Completed
• Conditions: Enterocolitis; Recurrent Clostridium Difficile Infection
• Intervention / Treatment: Biological: LFMT; Biological: LSFF

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.

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G2X8
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: LFMT; Lyophilized fecal microbiota transplant capsules	Biological: LFMT; Lyophilized fecal microbiota transplant
Experimental: LSFF; Lyophilized sterile fecal filtrate capsules	Biological: LSFF; Lyophilized sterile fecal filtrate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of RCDI	Proportion of subjects without RCDI	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resolution of RCDI	Proportion of subjects with sustained cure	24 weeks
Serious Adverse Events	Mortality directly attributable to CDI or treatment	8 weeks
Serious Adverse Events	Infection directly attributable to treatment	8 weeks
Minor Adverse Events	nausea	1 week
Minor Adverse Events	vomiting	1 week
Minor Adverse Events	abdominal pain	1 week
Difficulty in swallowing capsules	Reported by subjects as ranging between none, moderate or severe	1 week

Collaborators and Investigators

• Sponsor: Dina Kao
• Collaborators: University of Alberta

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2018
• Primary Completion (Actual): June 5, 2019
• Study Completion (Actual): October 10, 2019

Study Registration Dates

• First Submitted: November 6, 2017
• First Submitted That Met QC Criteria: November 22, 2017
• First Posted (Actual): November 27, 2017

Study Record Updates

• Last Update Posted (Actual): February 20, 2020
• Last Update Submitted That Met QC Criteria: February 19, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Infections; Communicable Diseases; Recurrence; Enterocolitis; Clostridium Infections
• Other Study ID Numbers: Pro00076309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No