Faecal microbiota transplantation for relapsing Clostridium difficile infection

Faecal microbiota transplantation for relapsing Clostridium difficile infection - FMT

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-003004-24-DK

Enrollment

Registered

2015-09-16

Start date

2015-11-13

Completion date

Unknown

Last updated

2020-11-09

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

Conditions

Relapsing Clostridium difficile infection MedDRA version: 19.0 Level: PT Classification code 10009657 Term: Clostridium difficile colitis System Organ Class: 10021881 - Infections and infestations

Interventions

Trade Name: Vancomycin Pharmaceutical Form: Capsule Trade Name: Dificlir (fidaxomicin) Pharmaceutical Form: Tablet

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Relapse of Clostridium difficile infection with previous trial of vancomycin or fidaxomicin 2. Age 18 years or older 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 32 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 32

Exclusion criteria

Exclusion criteria: 1. Pregnancy or breastfeeding 2. Does not speak or understand the Danish language 3. Current antibiotic treatment other than metronidazole, vancomycin, fidaxomicin 4. fulminant colitis which contraindicates medical treatment 5. physician's evaluation that the patient cannot tolerate project inclusion

Design outcomes

Secondary

Measure	Time frame
Secondary end point(s): 2a. Negative Clostridium difficile test 7 days after finishing treatment 2b. Treatment effect at 26 weeks;Timepoint(s) of evaluation of this end point: 2a. 17 days 2b. 28 weeks	—

Primary

Measure	Time frame
Main Objective: Compare 8-week cure rates from relapsing Clostridium difficile colitis following one of three treatments: 1) capsule vancomycin 125 mg 4 times daily 10 days + faecal microbiota transplantation 2) tablet fidamoxicin 200 mg twice daily 10 days 3) capsule vancomycin 125 mg 4 times daily 10 days;Secondary Objective: Within each treatment arm, describe need for rescue faecal microbiota transplantation, quality of life, cure at 26 weeks;Primary end point(s): 1a. Treatment effect, defined as both clinical effect (absence of abdominal pain and less than 3 bowel movements per day and a stool consistency of Bristol 5 or lower, corresponding to absence of diarhhoea) and microbiological effect (negative Clostridium difficile test) 8 weeks after finishing allocated treatment;Timepoint(s) of evaluation of this end point: 8 weeks after finishing allocated treatment (10 weeks after randomisation)	—

Measure

Time frame

Main Objective: Compare 8-week cure rates from relapsing Clostridium difficile colitis following one of three treatments: 1) capsule vancomycin 125 mg 4 times daily 10 days + faecal microbiota transplantation 2) tablet fidamoxicin 200 mg twice daily 10 days 3) capsule vancomycin 125 mg 4 times daily 10 days;Secondary Objective: Within each treatment arm, describe need for rescue faecal microbiota transplantation, quality of life, cure at 26 weeks;Primary end point(s): 1a. Treatment effect, defined as both clinical effect (absence of abdominal pain and less than 3 bowel movements per day and a stool consistency of Bristol 5 or lower, corresponding to absence of diarhhoea) and microbiological effect (negative Clostridium difficile test) 8 weeks after finishing allocated treatment;Timepoint(s) of evaluation of this end point: 8 weeks after finishing allocated treatment (10 weeks after randomisation)

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Countries

Denmark

Contacts

Public ContactChristian Lodberg Hvas

Aarhus University Hospital

christian.hvas@auh.rm.dk004578463895

Outcome results

None listed

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