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

Not Applicable

Withdrawn

• Conditions: Clostridium difficile diarrhoea; Infection - Other infectious diseases

• Registration Number: ACTRN12616000746437
• Lead Sponsor: Researchers as sponsor: Mr Jack Cross

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-06-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Withdrawn
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified