Gut Bugs for C. Difficile Infection (CDI) Study
Are oral Faecal Microbiome Transfer (FMT) capsules better than vancomycin in treating C. difficile infection (CDI), a potentially fatal condition?
What is the Gut Bugs for C. Difficile Infection (CDI) study?
This clinical trial based in Auckland, New Zealand investigates whether oral Faecal Microbiome Transfer (FMT) capsules are better than vancomycin in treating C. difficile infection (CDI), a potentially fatal condition.
What will participants be treated with?
All treatments in the trial will likely be superior to standard community-based care in New Zealand.
Why is this study important?
Treatment of CDI with metronidazole often does not resolve the infection and may lead to antibiotic resistance. With multiple recurrences of CDI, gastroenterologists or infectious disease physicians may turn to FMT. However, it is difficult to arrange and invasive (administered via colonoscopy or nasojejunal tube with sedation).
This trial tests a new approach to treat recurrent or refractory CDI by giving patients FMT capsules. These capsules are less invasive than traditional FMT methods and may avoid the need for antibiotics altogether. The findings of this research may result in FMT capsules becoming a more convenient and rapidly available treatment for patients and their clinicians in Aotearoa.
What is the study trying to find out?
This trial investigates whether FMT capsules are better than the international standard treatment of vancomycin or the same as vancomycin followed by FMT capsules in curing first recurrent or refractory CDI.
Communication between trial team and clinicians
The trial team oversees all CDI treatments, delivers care to patients' homes, and monitors side effects. A patient will be referred back to their clinician or to hospital if they encounter an unexpected clinical deterioration.
Clinicians will be informed about their patient's treatment outcomes without revealing the group allocation, except when necessary for patient care.
Who can take part?
We’re looking for patients who:
- Have received a diagnosis of first recurrent or refractory CDI (who are toxin positive)
- Are aged 16 to 90 years of age
- Can comfortably swallow capsules
- Live in the Auckland region
We will only exclude patients who are currently on systemic antibiotics (other than for CDI) or those hospitalised for severe CDI.
What does the study involve?
Upon referral, patients are randomly allocated to one of three groups: (1) FMT capsules alone, (2) vancomycin alone, or (3) vancomycin plus FMT.
Treatment duration varies by group, with groups 1 and 2 required to take a course of treatment over 10 consecutive days and group 3 over 12 consecutive days. Patients will undergo regular follow-up for six months after treatment initiation to monitor side effects, gut health and overall wellbeing.
What are the risks of FMT?
A potential risk is transmission of infectious organisms from a donor to the patients from the capsule material. To minimise this risk, all donor material is extensively screened for pathogens in alignment with the most rigorous international recommendations.
How can I find out more as a clinician?
For more details or to refer a patient, please contact us at gutbugscdiff@auckland.ac.nz.
You can also refer to the Awanui Labs results form of any patients who tested positive for CDI.
Additional information about the trial is available on the ANZCTR registry: https://www.anzctr.org.au/ACTRN12624000133538.aspx
How can I find out more as a patient?
For more details about how to participate in this trial, please contact us at gutbugscdiff@auckland.ac.nz and give us your New Zealand phone number so our team can contact you.
Additional information about the trial is available on the ANZCTR registry: https://www.anzctr.org.au/ACTRN12624000133538.aspx
This trial has been approved by the Health and Disability Ethics Committee (HDECs) (Reference: 2023 FULL 18301).
The Standing Committee on Therapeutic Trials (SCOTT) (reference 2023 SCOTT 19097) has approved the use of vancomycin capsules.
This study is funded by a philanthropic donation.