Faecal Microbiota Transplantation in Patients With Microscopic Colitis

NCT ID: NCT03275467

Last Updated: 2020-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2019-10-31

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 weight loss. The aetiology of MC is still unknown but it is hypothesized that MC is caused by a deregulated immune response to a luminal agent in predisposed individuals, and an important role of the intestinal microbiota is suggested.

In the current proof-of-concept study, the effect of faecal microbiota transfer (FMT) in 10 MC patients will be evaluated. FMT consists in the infusion of suspended stool from a healthy donor into the intestine of a patient with the aim to restore a disturbed intestinal microbiota.

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 of MC patients by restoring their disturbed intestinal microbiota. This procedure is known as faecal microbiota transplantation (FMT).

MC patients (n=10) will be randomised to receive FMT using stool from one of two healthy donors.

At baseline, blood samples and mucosal biopsies will be obtained from the descending colon. In addition, faecal samples will be collected and patients will complete symptom questionnaires. The first FMT will be administered by colonoscopy, FMT 2-3 by enemas. Faecal samples will be collected and questionnaires will be completed at different time points during the study. The patients will be followed-up at 6 weeks, 8 weeks, 12 weeks and 6 months after receiving FMT 1, however, the follow-up after 6 months will be optional. Additional biopsies from the descending colon and blood samples will be collected 6 weeks after the first FMT.

Conditions

Microscopic Colitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Faecal microbiota transfer (FMT)

Suspended stool from a healthy donor

Group Type: EXPERIMENTAL

Faecal microbiota transfer (FMT)

Intervention Type: OTHER

Suspended stool from a healthy donor

Interventions

Faecal microbiota transfer (FMT)

Suspended stool from a healthy donor

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

1. Signed informed consent

2. High-butyrate producing microbiota in faecal samples

3. Age: 18-65 years

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Region Örebro County

OTHER

Sponsor Role: collaborator

Örebro University, Sweden

OTHER

Sponsor Role: lead

Responsible Party

Robert Brummer

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert J Brummer, Professor, MD

Role: PRINCIPAL_INVESTIGATOR

Örebro University, Sweden

Locations

University Hospital Örebro

Örebro, Örebro County, Sweden

Countries

Sweden

Other Identifiers

2017/072

Identifier Type: -

Identifier Source: org_study_id