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.

All treatments in the trial will likely be superior to standard community-based care in New Zealand.

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.

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.

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.

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.

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.

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.

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

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