Multicentre Blinded Comparison of Lyophilized Sterile Fecal Filtrate to Lyophilized Fecal Microbiota Transplant in Recurrent Clostridioides Difficile Infection

Clostridium Difficile Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03806803
• Other study ID #: Pro00087406
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: March 21, 2019
• Est. completion date: June 2026

Study information

• Verified date: October 2023
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Fecal microbiota transplantation (FMT) is a treatment that restores the balance of gut bacteria and is the most effective treatment for patients who suffer from recurrent Clostridioides difficile infection (CDI) brought on by antibiotic use. Although highly effective, we do not understand how FMT actually works. Freeze-dried or lyophilized fecal microbiota transplant (LFMT) has been shown to be effective. Recently, filtered fecal slurry, free of any live bacteria, has also been shown to cure 5 such patients. The advantage of the filtered fecal slurry is that it may be safer to patients as it does not contain any live bacteria. We have conducted a pilot study comparing LFMT to lyophilized sterile fecal filtrate (LSFF) in 9 patients, and found that the success rate of treatment was 80% vs 75% in these 2 groups. Therefore we need to perform a larger multicenter study to compare LFMT to LSFF to determine the success rate of curing these patients.

Description:

This prospective double blind randomized study will enroll 248 patients with recurrent Clostridium difficile infection (RCDI) in a 1:1 ratio to receive either LFMT or LSFF by capsules. Patients will receive 15 capsules at week 0 and be assessed at weeks 1, 4, 8 and 24. Blood, stool and urine samples will be collected. If the first treatment fails, patients will be given open label LFMT from the same donor. If treatment fails again, FMT will be offered in the form and route at the treating physician's discretion.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 248
• Est. completion date: June 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 test, each occurring within 3 months of each other.
• CDI infection 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 effective contraception for the duration of the study

Exclusion Criteria:

• Severe or fulminant colitis
• Chronic diarrheal illnesses such as irritable bowel syndrome or inflammatory bowel disease unless under control or in remission 3 months prior to enrollment.
• Those taking or planning to take an investigational drug within 3 months of enrollment
• Chemotherapy or radiation therapy
• Oropharyngeal or significant esophageal dysphagia
• Ileus or small bowel obstruction
• Pregnant or planning to become pregnant within 3 months
• Breastfeeding or planning to breastfeed during the trial
• Active infection requiring antibiotics
• Life expectancy <6 months Those with history of total colectomy

Related Conditions & MeSH terms

• Clostridia Difficile Colitis
• Clostridium Difficile Diarrhea
• Clostridium Infections
• Diarrhea

Intervention

Biological:
• Lyophilized fecal microbiota transplant
15 capsules
• Lyophilized sterile fecal filtrate
15 capsules

Locations

Country	Name	City	State
Canada	University Of Calgary	Calgary
Canada	University of Alberta Hospital	Edmonton	Alberta
Canada	Mcgill University Health Centre	Montréal	Quebec
Canada	University of British Columbia	Vancouver	British Columbia
Canada	University of British Columbia	Victoria	British Columbia

Sponsors (4)

Lead Sponsor	Collaborator
University of Alberta	McGill University, University of British Columbia, University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resolution of RCDI	Proportion of patients without RCDI	8 weeks
Secondary	Resolution of RCDI	Proportion of patients with sustained cure	24 weeks
Secondary	Serious Adverse Events	Mortality directly attributable to CDI or treatment	8 weeks
Secondary	Serious Adverse Events	Infection directly attributable to treatment	8 weeks
Secondary	Minor Adverse Events	Nausea	1 week
Secondary	Minor Adverse Events	Vomiting	1 week
Secondary	Minor Adverse Events	Abdominal discomfort	1 week
Secondary	Difficulty swallowing capsules	Reported by patients as ranging between none, moderate or severe	1 week
Secondary	Fever	Temperature of >37.8C	1 week