Faecal microbiota transplantation in ulcerative colitis

Not Applicable

• Conditions: lcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN58082603
• Lead Sponsor: Abertawe Bro Morgannwg University LHB (UK)

Brief Summary

1. 2018 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/30341117

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-07-24
• Last Update Posted: 5 May 2019
• Study Completion: 2020-09-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Newly diagnosed histologically confirmed ulcerative colitis with inflammation limited to the rectum or rectosigmoid (within 40cm of anal verge as measured by flexible sigmoidoscope)
2. Age 18 years and above
3. Able to give full informed written consent
4. Willing to return for sequential FMT dosing and endoscopic assessment
5. Not in receipt of standard medical treatment for colitis such as steroids or 5-ASA ie treatment naive

Exclusion Criteria

1. Patients without a definitive diagnosis of UC (for example diagnosis of Crohn’s disease or infectious colitis)
2. Have colitis extending beyond 40cm from the anal verge
3. Have severe acute colitis (defined as greater than 6 bloodstained stools per 24 hrs with one of the following: pulse rate >90/ temperature >37.8’C/ haemoglobin <105g/L / ESR>30)
5. Abdominal tenderness on examination
6. Already commenced standard medical therapy for UC
7. Contraindication to oral bowel preparation
8. Allergy to study antibiotics
9. Age less than 18
10. Patient is within a vunerable group
11. Are pregnant
12. Are immuno-suppressed e.g. transplant patient
13. Known communicable disease;,at least 2 weeks full recovery from infectious disease e.g. chickenpox
14. Systemic autoimmunity, or atopic diseases
15. Previous prosthetic implant (for example metallic heart valve, joint replacement, ventriculoperitoneal shunt, cardiac stent)
16. Chronic pain syndromes (for example: fibromyalgia, chronic fatigue)
17. Neurologic, neuro-developmental or neurodegenerative disorders
18. Depression (requiring therapy)
19. Obesity (BMI>35)
20. Malignancy
21. Use of antibiotics for any indication within the past 3 months
22. Foreign travel to areas of enteric disease prevalence within 3 months
23. High risk sexual behaviour (examples: sexual contact with anyone with HIV/HTLV/AIDS or hepatitis B/C carrier, men who have sex with men (MSM))
24. Known exposure to HIV or hepatitis B/C
25. Current/previous use of injected drugs or intranasal cocaine
26. Tattooing, piercing, cosmetic botulinum toxin (Botox) or permanent makeup within 120 days (in line with Welsh Blood Transfusion guidelines)
27. Recent transfusion, transplant or skin graft
28. Risk factors for variant Creutzfeldt-Jakob disease e.g. blood transfusion or transplant after 1st January 1980

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. Remission of UC (mucosal healing) at 12 weeks as assessed by sigmoidoscopy, and patients response. Will also be measured utilising the Mayo scoring system for assessment of ulcerative colitis activity at 12 weeks, with remission defined as a Mayo score = 2 with an endoscopic Mayo score of 0.<br> 2. Successful engraftment of donor faecal microbiota at 12 weeks as analysed by 16S sequencing<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Rate of recruitment of patients<br> 2. Disease specific severity scoring after treatment<br> 3. Histological grading of colitis severity after treatment<br> 4. Mucosal immunological response to treatment<br> 5. Rate of development of adverse effects of FMT<br>