None listed
Conditions
Brief summary
The majority of reported FMT procedures have been performed with fresh stool suspensions from related donors. This approach has practical barriers that hinder the development of scientifically sound treatment protocols. The use of fresh donations requires prior identification and screening of a suitable donor, thus precluding the use of FMT in acute situations. Furthermore, the limited viability of fresh samples, usually estimated at up to 6 hours, makes thorough screening of donors and donation aliquots impractical. To address these issues Yongster and colleagues have studied the use of a pre-prepared, frozen inoculum from unrelated donors delivered by both endoscopic and capsulized routes, however both of these studies have been pilot studies. The capsulized form of FMT when compared to FMT delivered by endoscopic means this method may have positive effects on: The timing of the procedure due to reduced logistical issues, the safety of the procedure (reduced risk of endoscopic/anaesthesia complications) and a reduction of overall cost to the health budget Strengthening the evidence base and clinical experience behind frozen, oral FMT will be of benefit to patients, staff and health services. Patients will be offered oral FMT using pre-made frozen capsules with the FM souced from unrelated donors
Interventions
Patients with treatment refractory C. difficle diarrhoea will be offered capsulised faecal matter transplantation as treatment. The faecal matter will be from an unrelated donor and once capsulised, frozen until required in the clinic.
Donors are to be healthy volunteers, 18-50 years old, nil previous medical conditions, taking no medications, faeces and blood will be screened for known transmissible pathogens and pass the Australian Red Cross Blood Donor questionaire.
Patients will recieve 15
Patients with treatment refractory C. difficle diarrhoea will be offered capsulised faecal matter transplantation as treatment. The faecal matter will be from an unrelated donor and once capsulised, frozen until required in the clinic. Donors are to be healthy volunteers, 18-50 years old, nil previous medical conditions, taking no medications, faeces and blood will be screened for known transmissible pathogens and pass the Australian Red Cross Blood Donor questionaire. Patients will recieve 15 capsules on 2 consecutive days and be followed up for symptom resolution and adverse events for up to 6 months. Each inoculum will be prepared from the faeces of a single donor and a full treatment of 30 capsules contain sieved, concentrated material derived from approximately 50g of faecal matter (ie approximately 1.66g per capsule). Patients will be offered the capsules by the investigators in the clinic and instructed to take them orally. Adherence will be directly observed by the investigator at this time.
Sponsors
Researchers as sponsor: Mr Jack Cross
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
Recipients: Any patient aged >18 years with treatment refractory CDAD (at least 2 failed treatments or requiring long term suppressive treatment) who does not have any of the exclusion criteria Donors: healthy, non-pregnant adults aged 18-50 years, taking no medications BMI of 18.5-25, no significant medical history (with the exception of resolved traumatic injury or routine surgery), pass the Australian Red Cross Blood Donor Questionnaire (see appendix), passes general physical examination, refrained from eating common allergens within 5 days of stool donation, otherwise not to alter their diet
Exclusion criteria
Recipients: Known delayed gastric emptying disorder, or symptoms consistent with delayed gastric emptying. Pregnant mothers. Donors: Any past or current malignancy including GI malignancy or polyposis Personal or family history of inflammatory bowel disease or unexplained GI illness History of irritable bowel syndrome, excessive gas, bloating, lymphocytic colitis, idiopathic chronic constipation, chronic use of laxatives or chronic diarrhoea Any chronic medications Use of probiotics or any OTC aids for regulating digestion Antibiotics within the preceding 6 months Major immunosuppressive medications, e.g. calcineurin inhibitors, exogenous glucocorticoids, biologic agents, etc. Systemic anti-neoplastic agents Recent (last 5 days) ingestion of a potential allergen (e.g., nuts, shellfish, eggs, peanuts) History of gastrointestinal surgery (e.g., gastric bypass) Metabolic syndrome Neurological, neurodevelopmental disorder e.g. Parkinson’s disease, autism, etc. Systemic autoimmunity, e.g., multiple sclerosis, psoriasis, vasculitis, connective tissue disease, any rheumatologic or inflammatory condition Atopic diseases, e.g. asthma and eczema, food allergies, eosinophilic disorders of the gastrointestinal tract Chronic pain syndromes, e.g., chronic fatigue syndrome, fibromyalgia
Outcome results
None listed