Faecal microbiota transplantation for relapsing Clostridium difficile infectio

Phase 1

• Conditions: Relapsing Clostridium difficile infection; MedDRA version: 19.0Level: PTClassification code 10009657Term: Clostridium difficile colitisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2015-003004-24-DK
• Lead Sponsor: Aarhus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-09-16
• Last Update Posted: 9 November 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 64

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Compare 8-week cure rates from relapsing Clostridium difficile colitis following one of three treatments: <br>1) capsule vancomycin 125 mg 4 times daily 10 days + faecal microbiota transplantation<br>2) tablet fidamoxicin 200 mg twice daily 10 days<br>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)

Secondary Outcome Measures

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