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

NCT03806803 | Completed Phase 2 DMC

• 1 other identifier: Pro00087406
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Clostridia Difficile Colitis; Clostridium Difficile Diarrhea

Outcome Measures

Primary Outcomes (1)

• Resolution of RCDI

  Proportion of patients without RCDI

  8 weeks

Secondary Outcomes (8)

• Resolution of RCDI

  24 weeks

• Serious Adverse Events

  8 weeks

• Serious Adverse Events

  8 weeks

• Minor Adverse Events

  1 week

• Minor Adverse Events

  1 week

Study Arms (2)

LFMT

ACTIVE COMPARATOR

Lyophilized fecal microbiota transplant capsules

Biological: Lyophilized fecal microbiota transplant

LSFF

EXPERIMENTAL

Lyophilized sterile fecal filtrate capsules

Biological: Lyophilized sterile fecal filtrate

Interventions

Lyophilized fecal microbiota transplant BIOLOGICAL

15 capsules

LFMT

Lyophilized sterile fecal filtrate BIOLOGICAL

15 capsules

LSFF

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead
• University of British Columbia: collaborator
• University of Calgary: collaborator
• McGill University: collaborator

Study Sites (5)

University of Alberta Hospital

Edmonton, Alberta, T6G 2X8, Canada

Location

University of British Columbia

Vancouver, British Columbia, Canada

Location

University of British Columbia

Victoria, British Columbia, V8R 1J8, Canada

Location

Mcgill University Health Centre

Montreal, Quebec, Canada

Location

University Of Calgary

Calgary, T2N 2T9, Canada

Location

Related Publications (1)

• Kao D, Wong K, Lee C, Steiner T, Franz R, McDougall C, Silva M, Schmidt TSB, Walter J, Loebenberg R, Monaghan TM, Giebelhaus RT, Harynuk JJ, Xu H, Yaskina M, MacDonald KV, Marshall DA, Louie T. Effects of lyophilised faecal filtrate compared with lyophilised donor stool on Clostridioides difficile recurrence: a multicentre, randomised, double-blinded, non-inferiority trial. Lancet Gastroenterol Hepatol. 2025 Nov;10(11):986-997. doi: 10.1016/S2468-1253(25)00190-6. Epub 2025 Sep 22.

  PMID: 40997843 DERIVED

MeSH Terms

Conditions

Enterocolitis, Pseudomembranous

Condition Hierarchy (Ancestors)

Clostridium Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Enterocolitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Dina Kao, MD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: LFMT and LSFF appear identical. Randomization is performed by lab staff not involved in any aspect of treatment administration or care.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: double blind randomized

Study Record Dates

• First Submitted: January 14, 2019
• First Posted: January 16, 2019
• Study Start: March 21, 2019
• Primary Completion: March 12, 2024
• Study Completion: March 12, 2024
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CA (5)