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

• Sponsor: Dina Kao (Other)
• Overall Status: Completed
• CT.gov ID: NCT03353506
• Collaborator: University of Alberta (Other)
• Enrollment: 11
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.8
• Patients Per Site Per Month: 0.6

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Enterocolitis; Recurrent Clostridium Difficile Infection	Biological: LFMT; Biological: LSFF	Phase 2

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 Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double blind randomizeddouble blind randomized
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: Feb 14, 2018
• Actual Primary Completion Date: Jun 5, 2019
• Actual Study Completion Date: Oct 10, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Resolution of RCDI [8 weeks]

   Proportion of subjects without RCDI

Secondary Outcome Measures

1. Resolution of RCDI [24 weeks]

   Proportion of subjects with sustained cure

2. Serious Adverse Events [8 weeks]

   Mortality directly attributable to CDI or treatment

3. Serious Adverse Events [8 weeks]

   Infection directly attributable to treatment

4. Minor Adverse Events [1 week]

   nausea

5. Minor Adverse Events [1 week]

   vomiting

6. Minor Adverse Events [1 week]

   abdominal pain

7. Difficulty in swallowing capsules [1 week]

   Reported by subjects as ranging between none, moderate or severe

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alberta	Edmonton	Alberta	Canada	T6G2X8

Sponsors and Collaborators

• Dina Kao
• University of Alberta

Investigators

• Principal Investigator: Dina Kao, MD, University of Alberta

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dina Kao, Medical Doctor, University of Alberta
• ClinicalTrials.gov Identifier: NCT03353506
• Other Study ID Numbers: Pro00076309
• First Posted: Nov 27, 2017
• Last Update Posted: Feb 20, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Infections; Communicable Diseases; Clostridium Infections; Enterocolitis; Recurrence

Study Results

No Results Posted as of Feb 20, 2020