Status:
COMPLETED
Faecal Microbiota Transplantation in Patients With Microscopic Colitis
Lead Sponsor:
Örebro University, Sweden
Collaborating Sponsors:
Region Örebro County
Conditions:
Microscopic Colitis
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
Microscopic colitis (MC) is a disease with chronic inflammation of the colon that is mostly diagnosed in middle-aged or elderly women. Patients suffer from chronic watery diarrhoea, abdominal pain and...
Detailed Description
This will be an intervention pilot study with a 12-week and an optional 6-months follow-up period. It will be investigated if the infusion of suspended stool from healthy donors improves the symptoms ...
Eligibility Criteria
Inclusion
- Inclusion criteria for patients:
- Signed informed consent
- Active MC diagnosis, defined as \>3 stools a day from which at least one should be watery
- Willingness to stop budesonide treatment during participation in the trial
- Age: 18-70 years
- Exclusion criteria for patients
- Previous complicated gastrointestinal surgery
- Malignant disease except non-melanoma skin cancer
- Dementia, severe depression, major psychiatric disorder, or other incapacity for adequate cooperation
- C. difficile or other current gastroenteritis
- Females who are pregnant or breast-feeding
- Severe endometriosis
- Antimicrobial treatment 4 weeks prior to first screening visit
- Antimicrobial prophylaxis (eg. acne, urinary tract infection)
- Regular consumption of probiotic products 4 weeks prior to randomization
- Recently diagnosed lactose intolerance (less than 6 months prior to first screening visit)
- Recently diagnosed coeliac disease (less than 6 months prior to first screening visit)
- Regular intake of NSAIDs (non steroidal anti-inflammatory drugs)
- Abuse of alcohol or drugs
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
- Inclusion criteria for donors
- Signed informed consent
- High-butyrate producing microbiota in faecal samples
- Age: 18-65 years
- Exclusion criteria for donors
- Known organic gastrointestinal disease (e.g. IBD, IBS, chronic diarrhoea or constipation)
- First degree relative with IBD
- History of or present gastrointestinal malignancy or polyposis
- Recent (gastrointestinal) infection (within last 6 months)
- History of major gastrointestinal surgery (e.g. gastric bypass)
- Eosinophilic disorders of the gastrointestinal tract
- Current communicable disease (e.g. upper respiratory tract infection)
- Malignant disease and/or patients who are receiving systemic anti-neoplastic agents
- Psychiatric diseases (e.g. dementia, depression, schizophrenia, autism, Asperger Syndrome) or other incapacity for adequate cooperation
- Chronic neurological/neurodegenerative diseases (e.g. Parkinson's disease, multiple sclerosis)
- Autoimmune disease and/or patients receiving immunosuppressive medications
- Major relevant allergies (e.g. food allergy, multiple allergies)
- Chronic pain syndromes (e.g. fibromyalgia)
- Chronic fatigue syndrome
- HIV, hepatitis A, B, C or known exposure within the recent 12 months
- Obesity (BMI\>30) or metabolic syndrome
- Antimicrobial treatment or prophylaxis within the last 3 months
- Other chronic use of drugs that may affect the microbiome, e.g. proton pump inhibitors
- First degree relative with cardiovascular thrombosis before 50 years of age
- Females who are pregnant or breast-feeding
- Known clinically significant abnormal laboratory values
- Participation in high-risk sexual behaviours
- Abuse of alcohol or drugs
- Tattoo or body piercing within the last 6 months
- Travelling in countries with low hygiene or high infection risk for endemic diarrhoea within the last 6 months
- 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)
- 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))
- Calprotectin \> 50 μg/g of faeces
- Positive blood testing for HIV, Hepatitis A, B, C, syphilis, Human T-lymphotropic virus (HTLV), cytomegalovirus (CMV) and Epstein Barr Virus (EBV)
- Any clinically significant disease/condition which in the investigator's opinion could interfere with the results of the trial
Exclusion
Key Trial Info
Start Date :
June 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 31 2019
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT03275467
Start Date
June 1 2017
End Date
October 31 2019
Last Update
February 21 2020
Active Locations (1)
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1
University Hospital Örebro
Örebro, Örebro County, Sweden, 70185