NCT03834038

Lyophilized Fecal Microbiota Transplantation for Recurrent Clostridioides Difficile Infection

Completed NA Results posted Last updated 23 September 2024

What this trial tests

NA trial testing Lyophilized Fecal Microbiota Transplantation in Recurrent Clostridium Difficile Infection in 158 participants. Completed in 17 March 2020.

Timeline

1 October 2015

Primary endpoint
1 March 2018

17 March 2020

Quick facts

Lead sponsor	Vancouver Island Health Authority
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	158
Start date	1 October 2015
Primary completion	1 March 2018
Estimated completion	17 March 2020
Sites	1 location across Canada

Drugs / interventions tested

• Lyophilized Fecal Microbiota Transplantation — full drug profile →

Conditions studied

• Recurrent Clostridium Difficile Infection — all drugs for Recurrent Clostridium Difficile Infection →

Sponsor

Vancouver Island Health Authority — full company profile →

Who can join

12 and older, any sex, with Recurrent Clostridium Difficile Infection. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

No Recurrence of CDI-related Diarrhea at 13 Weeks From Last LYO-FMT Primary · 13 weeks from last FMT

No recurrence of CDI-related diarrhea at 13 weeks following last FMT without the need for an intervention antibiotics or additional FMT specifically for CDI recurrence.

Group	Value	95% CI
Open Label Lyophilized Fecal Microbiota Transplantation	106

Adverse events — posted to ClinicalTrials.gov

Time frame: 1 year 2 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Open Label Lyophilized Fecal Microbiota Transplantation

Serious: 14/158 (9%)

Deaths: 10/158

Serious adverse events (6 terms)

Reaction	System	Open Label Lyophilized Fec…
Cardiac event	Cardiac disorders	—
C. difficile infection	Infections and infestations	—
leukocytosis	Blood and lymphatic system disorders	—
Falls	Injury, poisoning and procedural complications	—
Respiratory disorder	Respiratory, thoracic and mediastinal disorders	—
Genitourinary dysfunction	Renal and urinary disorders	—

Other adverse events (1 terms — click to expand)

Reaction	System	Open Label Lyophilized Fec…
Common Non-Serious	Gastrointestinal disorders	—

Most-reported serious reactions: Cardiac event, C. difficile infection, leukocytosis, Falls, Respiratory disorder, Genitourinary dysfunction.

Data from ClinicalTrials.gov NCT03834038 adverse events section.

Sponsor's own description

The primary goal is to study participants with recurrent C. difficile infection (CDI) treated with lyophilized fecal microbiota transplantation (FMT). The safety, clinical response and relapse rate in patients will be assessed.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.