Specialty: Gastroenterology, Primary sub-specialty: Gastroenterology
Conditions
Interventions
Following confirmation of eligibility criteria and written informed consent having been obtained for screening, in accordance with Good Clinical Practice standards, patients are provided IBD diares an
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Clinically confirmed ulcerative colitis (UC) for at least =12 weeks prior to the screening visit 2. Aged 16-70 years 3. Partial Mayo score of =4 and =8 despite stable 5ASA+/- thiopurine, methotrexate or no treatment 4. Rectal bleeding subscore of =1 on the partial Mayo 5. Written, signed informed consent to the study 6. Males or females
Exclusion criteria
Exclusion criteria: Donors: 1. GI history of: 1.1. Inflammatory bowel disease 1.2. Irritable bowel syndrome, idiopathic chronic constipation or chronic diarrhoea 1.3. Gastrointestinal malignancy or known polyposis 1.4. Celiac disease 1.5. Congenital or chronic liver disease 1.6. Per rectal bleeding 1.7. Major gastrointestinal surgery (eg gastric bypass) 2. Autoimmune history of systemic autoimmunity including: 2.1. Connective tissue disease 2.2. Thyroid disease 2.3. Inflammatory arthritis 2.4. Psoriasis 2.5. Alopecia 3. Atopic disease inc: 3.1. Asthma 3.2. Atopic dermatitis 3.3. Eczema 3.4. Eosinophilic disorders of the gastrointestinal tract 4. Chronic pain history of: 4.1. Chronic fatigue syndrome 4.2. Fibromyalgia 5. Cardiovascular history of a cardiovasular or metabolic syndrome including: 5.1. Diabetes (type 1 or type 2) 5.2. High blood pressure 5.3. High cholesterol 5.4. High fasting glucose 5.5. Heart disease (eg atherosclerosis, myocardial infarction, congestive heart failure) 6. Neurological history of neurological conditions including: 6.1. Multiple Sclerosis 6.2. Parkinson’s disease 6.3. Alzheimer’s disease or dementia disorders 7. Immunosuppression history of any major immunosuppressive mechanisms including: 7.1. Calcineurin inhibitors 7.2. Exogenous glucocorticoids 7.3. Biological agents 7.4. Anti-TNF factors 7.5. Systemic chemotherapeutic anti-neoplastic agents 7.6. Transplantation (eg solid organ, bone marrow, cornea etc) 8. Mental health and well being history of having been diagnosed by a clinician with any of the following: 8.1. Depression 8.2. Bipolar disorder 8.3. Schizophrenia or delusional disorder 8.4. Eating disorder (eg anorexia and / or bulimia) 9. Infectious diseases: 9.1. Known to have HIV, HBV and/or HCV infection 9.2. Known to have been exposed to HIV, HBV and/or HCV in the preceding 12 months 9.3. Risk of Creutzfeldt-Jakob disease (CJD) or variant CJD 9.4. Originate from or share sexual partners or have a parent who originates from areas with high-incidence Human T-cell 10. Lymphotropic Virus eg Caribbean, Japan, South America and Africa. 10.1. Positive microbiology testing for any of the pathogens described donor testing schedule 11. High risk activities for bloodborne infections Engaged in any known high risk activities for blood-borne infections, including: 11.1. Sexual contact with an individual with known or suspected HIV, AIDS and/or hepatitis 11.2. Sexual contact with a man who has had sex with another man 11.3. Sex for drugs or money (both receiving and/or paying) 11.4. Use of illicit drugs including IV, oral or inhaled 11.5. Tattoo or body piercing in the preceding 6 months 12. Medications, probioics and vaccinations 12.1. History of proton pump inhibitor use 12.2. History of antibiotics within the preceding 3 months 12.3. History of receiving growth hormone, insulin from cows or cloting factor concentrates 12.4. History of receiving an experimental medicine or experimental vaccine 12.5. History of VSL3 probiotic food supplement or Mutaflor probiotic use 12.6. History of receiving a live vaccination within the preceding one month 13. Dietary, social and travel history 13.1. Participation in a strict vegan diet 13.2. Work or volunteering activities in which the donor comes into contact with animal or human tissues 13.3. Any previous tobacco use 13.4. Travelled outside Europe, North America or Australasia in the preceding 3 months 14. Family hisotry: 14.1. History of a first degree relative diagnosed with colon can
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Clinical response (primary measure of efficacy) defined as =3 point reduction in the full Mayo score from randomisation to week 8, and 30% reduction from randomisation and at least 1 point reduction of rectal bleeding subscore or an absolute rectal bleeding subscore of 0 or 1 2. Time to clinical response where clinical response is defined as =2 point reduction in partial Mayo 3. Clinical remission is measured using the full Mayo score of =2, with no subscore >1 at week 8 4. Participant’s weight is measured using scales at week 8 and week 12 5. Quality of Life (QoL) is meaured using generic Short-Form 36 (SF-36) and the disease specific Inflammatory Bowel Disease Questionnaire (IBDQ) at week 8 and week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Faecal calprotectin is measured from sample collected at randomisation, weeks 2, 4, 6, 8 & 12 2. Measures of microbiome (faecal and mucosal) is measured from sample collected at randomisation, weeks 4, 6, & 8 3. Mucosal healing is measured from biopsies at randomisation and week 8 4. Urinary metabolome (SCFA) is measured from sample collected at randomisation, weeks 8 & 12 5. CRP is measured from sample collected at randomisation, weeks 2, 4, 6, 8 & 12 6. Association between the donor’s dietary profile and microbiome 7. Time from stool donation to treatment | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed