Gut Bugs for C. Difficile Infectio

Phase 3

Recruiting

Conditions: Recurrent Clostridioides difficile infection
Refractory Clostridioides difficile infection
Infection - Studies of infection and infectious agents
Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Registration Number: ACTRN12624000133538

Lead Sponsor: niversity of Auckland

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 84

Inclusion Criteria

Study participants (recipients) will have to meet the following inclusion criteria:

1.Aged 16 to 90 years; AND
2.Ability to swallow all treatment capsules; AND
3.Having:
a.First recurrent Clostridioides difficile infection; OR
b.Refractory Clostridioides difficile infection.

Exclusion Criteria

As a real-world trial examining FMT effectiveness, there will be minimal exclusion criteria. However, patients meeting the three below will be excluded:

1. Current systemic antibiotic treatment except if prescribed for Clostridioides difficile infection
2. Severe allergy to foods and/or common medications
3. Current hospitalisation because of severe Clostridioides difficile infection, defined as having at least one of the following that is not directly attributable to a non-clostridioides difficile infection illness (e.g., infection):
a.Fever (core body temperature of greater than 38.5°C);
b.Marked leukocytosis (leucocyte count greater than 15 x109/L);
c.Serum creatinine rise greater than 50% above baseline or if no baseline available greater than 50% above the upper limit of the age-specific reference range;

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of sustained Clostridioides difficile infection cure 12 weeks after treatment commencement with FMT alone compared to vancomycin hydrochloride alone[Clinical evaluation. <br><br>Clostridioides difficile infection sustained cure is defined as meeting one of the criteria below: <br>a. No diarrhea for greater than or equal to 2 consecutive days between greater than 4 days and 12 weeks after treatment initiation; OR<br>b. Recurrence of diarrhea for greater than or equal to 2 consecutive days between greater than 4 days and 12 weeks after treatment initiation; AND<br> Negative stool test(s) for C. difficile toxin antigen during that time. Baseline, 2, 4 and 5 days and 1, 4, and 12 weeks after treatment initiation (primary timepoint). ]

Secondary Outcome Measures