Efficacy of oral, capsulised, frozen faecal matter transplant for the treatment of relapsing clostridium difficile diarrhoea in adults.

Researchers as sponsor: Mr Jack Cross0 个研究点目标入组 19 人开始时间: 2016年6月7日最近更新: 2020年1月13日

试验速览

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•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
•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

•Recipients:
•Known delayed gastric emptying disorder, or symptoms consistent with delayed gastric emptying. Pregnant mothers.
•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

发起方

Researchers as sponsor: Mr Jack Cross