Faecal Microbiota Transplantation in Patients With Microscopic Colitis

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT03275467
• Date of registration: 28/08/2017
• Prospective Registration: No
• Primary sponsor: Örebro University, Sweden
• Public title: Faecal Microbiota Transplantation in Patients With Microscopic Colitis
• Scientific title: Faecal Microbiota Transplantation in Patients With Microscopic Colitis
• Date of first enrolment: June 1, 2017
• Target sample size: 10
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03275467
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Sweden

Contacts

• Name: Robert J Brummer, Professor, MD
• Affiliation: Örebro University, Sweden

Key inclusion & exclusion criteria

Inclusion criteria for patients:

1. Signed informed consent

2. Active MC diagnosis, defined as >3 stools a day from which at least one should be
watery

3. Willingness to stop budesonide treatment during participation in the trial

4. Age: 18-70 years

Exclusion criteria for patients

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

Inclusion criteria for donors

1. Signed informed consent

2. High-butyrate producing microbiota in faecal samples

3. Age: 18-65 years

Exclusion criteria for donors

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



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Microscopic Colitis

Intervention(s)

Other: Faecal microbiota transfer (FMT)

Primary Outcome(s)

Proportion of MC patients in remission six weeks after the first FMT. [Time Frame: 6 weeks]

Secondary Outcome(s)

Changes in faecal and mucosal microbiota composition [Time Frame: faecal: 6 weeks, 8 weeks, 12 weeks, 6 months; mucosal: 6 weeks]

Changes in general health and symptom questionnaire scores [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in number and form of bowel movements [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in immune cell composition of colonic biopsies [Time Frame: 6 weeks]

Changes in lymphocyte infiltration [Time Frame: 6 weeks]

Changes in gastrointestinal symptom questionnaire scores [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in hospital and anxiety depression scores [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in general health questionnaire scores [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in quality of life questionnaire scores [Time Frame: 6 weeks, 8 weeks, 12 weeks, 6 months]

Changes in subepithelial collagen layer [Time Frame: 6 weeks]

Secondary ID(s)

2017/072

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Region Örebro County