Faecal Microbiota Transplantation in Patients With Microscopic Colitis

Exclusion Criteria

• •1. Previous complicated gastrointestinal surgery
• •2. Malignant disease except non-melanoma skin cancer
• •3. Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
• •4. C. difficile or other current gastroenteritis
• •5. Females who are pregnant or breast-feeding
• •6. Severe endometriosis
• •7. Antimicrobial treatment 4 weeks prior to first screening visit
• •8. Antimicrobial prophylaxis (eg. acne, urinary tract infection)
• •9. Regular consumption of probiotic products 4 weeks prior to randomization
• •10. Recently diagnosed lactose intolerance (less than 6 months prior to first screening visit)
• •11. Recently diagnosed coeliac disease (less than 6 months prior to first screening visit)
• •12. Regular intake of NSAIDs (non steroidal anti-inflammatory drugs)
• •13. Abuse of alcohol or drugs
• •14. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
• •1. Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhoea or constipation)
• •2. First degree relative with IBD
• •3. History of or present gastrointestinal malignancy or polyposis
• •4. Recent (gastrointestinal) infection (within last 6 months)
• •5. History of major gastrointestinal surgery (e.g. gastric bypass)
• •6. Eosinophilic disorders of the gastrointestinal tract
• •7. Current communicable disease (e.g. upper respiratory tract infection)
• •8. Malignant disease and/or patients who are receiving systemic anti-neoplastic agents
• •9. Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation
• •10. Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
• •11. Autoimmune disease and/or patients receiving immunosuppressive medications
• •12. Major relevant allergies (e.g. food allergy, multiple allergies)
• •13. Chronic pain syndromes (e.g. fibromyalgia)
• •14. Chronic fatigue syndrome
• •15. HIV, hepatitis A, B, C or known exposure within the recent 12 months
• •16. Obesity (BMI\>30) or metabolic syndrome
• •17. Antimicrobial treatment or prophylaxis within the last 3 months
• •18. Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors
• •19. First degree relative with cardiovascular thrombosis before 50 years of age
• •20. Females who are pregnant or breast-feeding
• •21. Known clinically significant abnormal laboratory values
• •22. Participation in high-risk sexual behaviours
• •23. Abuse of alcohol or drugs
• •24. Tattoo or body piercing within the last 6 months
• •25. Travelling in countries with low hygiene or high infection risk for endemic diarrhoea within the last 6 months
• •26. Positive stool testing for C. difficile, ova and parasites (e.g. Cyclospora, Isospora, Cryptosporidium), enteric pathogens (e.g. enterohaemorrhagic E. coli, Salmonella, Shigella, Yersinia, Campylobacter, Giarda antigen, amoebas)
• •27. Positive stool testing for multiresistant bacteria (e.g. extended-spectrum beta- lactamase (ESBL) producing organisms, multi-resistant Gram-negative bacilli (MRGN) 3 and 4, vancomycin-resistant enterococci (VRE) or methicillin-resistant Staphylococcus aureus (MRSA))
• •28. Calprotectin \> 50 μg/g of faeces
• •29. Positive blood testing for HIV, Hepatitis A, B, C, syphilis, Human T-lymphotropic virus (HTLV), cytomegalovirus (CMV) and Epstein Barr Virus (EBV)
• •30. Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial