Intestinal flora therapy or antibiotics for primary Clostridium difficile infection

Comparative effectiveness of intestinal microbiota versus vancomycin for primary Clostridium difficile infection – randomized trials. - COLONIZE

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2018-004580-31-NO

Enrollment

188

Registered

2019-01-02

Start date

2019-03-21

Completion date

Unknown

Last updated

2019-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Clostridium difficile infection

Interventions

Trade Name: Vancomycin Pharmaceutical Form: Capsule, hard

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients, =18 years with primary C. difficile infection defined as: •Diarrhea as defined by the WHO (=3 loose stools per day), and •Positive stool test for toxin producing C. difficile, and •No evidence of previous C. difficile infection during 365 days before enrolment. Written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 188 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 188

Exclusion criteria

Exclusion criteria: Presence of other stool pathogens known to cause diarrhea. Ongoing or scheduled (e.g. surgery prophylaxis) antibiotic treatment for other infections that cannot be stopped for 12 hours after treatment allocation. Inflammatory bowel disease or microscopic colitis. < 3 months life expectancy. Serious immunodeficiency, defined as one of the following: -Ongoing or recent chemotherapy and current or expected neutropenia with neutrophil count of < 500/µL. -Active severe immunocompromising disease. Inability to comply with protocol requirements. Need of intensive care or American Society of Anesthesiologists (ASA) Physical Status classification IV or V. Known irritable bowel syndrome, diarrheal type. Pregnancy or nursing. Known or suspected toxic megacolon or ileus. Total or subtotal colectomy, ileostomy or colonostomy. Known hypersensitivity or other contraindications to vancomycin.

Design outcomes

Primary

Measure	Time frame
Main Objective: To investigate if fecal microbiota transplantation is non-inferior to vancomycin to achieve clinical cure of primary Clostridium difficile infection. ;Secondary Objective: Identification of adverse effects related to fecal microbiota transplantation in primary C. difficile infection.;Primary end point(s): Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent Clostridium difficile infection during 60 days after treatment start, with the assigned treatment alone.;Timepoint(s) of evaluation of this end point: Day 60 after study enrollment.	—

Measure

Time frame

Main Objective: To investigate if fecal microbiota transplantation is non-inferior to vancomycin to achieve clinical cure of primary Clostridium difficile infection. ;Secondary Objective: Identification of adverse effects related to fecal microbiota transplantation in primary C. difficile infection.;Primary end point(s): Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent Clostridium difficile infection during 60 days after treatment start, with the assigned treatment alone.;Timepoint(s) of evaluation of this end point: Day 60 after study enrollment.

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Secondary

Measure	Time frame
Secondary end point(s): 1. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with or without the need of additional treatment (FMT, metronidazole or vancomycin). 2. Proportion of patients with adverse events. 3. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, and without recurrent C. difficile infection within 365 days after treatment start. 4. Health-economic analysis of the two compared treatment modalities ; Timepoint(s) of evaluation of this end point: 1. Day 60 after study enrollment. 2. Day 60 and 365 after study enrollment 3. Day 365 after study enrollment. 4. Day 365 after study enrollment.	—

Measure

Time frame

Secondary end point(s): 1. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, with or without the need of additional treatment (FMT, metronidazole or vancomycin). 2. Proportion of patients with adverse events. 3. Proportion of patients with primary clinical cure at day 14 after treatment start and no recurrent C. difficile infection during 60 days after treatment start, and without recurrent C. difficile infection within 365 days after treatment start. 4. Health-economic analysis of the two compared treatment modalities ; Timepoint(s) of evaluation of this end point: 1. Day 60 after study enrollment. 2. Day 60 and 365 after study enrollment 3. Day 365 after study enrollment. 4. Day 365 after study enrollment.

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Countries

Norway

Contacts

Public Contactwww.ous-research.no

Oslo University Hospital

k.k.garborg@medisin.uio.no

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026