Ulcerative Colitis Digestive System Ulcerative Colitis
Conditions
Interventions
All participants will be required to take one 5.5g sachet which contains 2.7g prebiotic food supplement (Bimuno, Clasado) daily for six weeks. This will be reconstituted with water and participants wi
Sponsors
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged 16-65 years 2. Women who are not currently pregnant or lactating 3. Mildly active UC defined by Gastroenterologist’s opinion and supported one or more of 3.1. CRP above normal for referring centre 3.2. Faecal calprotectin greater than 150 ug/g 3.3. Recent endoscopic evidence of active disease 4. No anticipated changes to dose or type of UC medication for the seven week trial period 5. Patients without another major medical condition (e.g. diabetes, psychiatric or current eating disorders), other gastrointestinal disease or condition (e.g. Crohn’s disease, coeliac disease, lactose or dairy allergy), known enteropathogen or history of previous major GI surgery, except cholecystectomy, appendectomy and haemorrhoidectomy 6. Participants who have not received bowel preparation for investigative procedures in the four weeks prior to the study 7. Participants who have not taken antibiotics, prebiotics or probiotics (in other food products or as supplements) in the four weeks prior to, or during the study 8. Individuals able to give informed consent 9. Individuals willing to participate
Exclusion criteria
Exclusion criteria: 1. Factors affecting immunity and inflammation 1.1. Started azathioprine, mercaptopurine or thioguanine therapy less than 12 weeks previously or who have changed dose in the previous 6 weeks 1.2. Started 5-asa (mesalazine) therapy less than 8 weeks previously or who have changed dose in the previous 2 weeks 1.3. Prescribed use of steroids 1.4. Prescribed use of methotrexate 1.5. Prescribed use of the immunosuppressant drugs ciclosporin and tacrolimus 1.6. Prescribed use of anti-inflammatory drugs e.g. infliximab, vedoluzimab, golimumab, adolimubab 1.7. Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) 2. Factors which may confound impact of prebiotic supplementation 2.1. Use of antibiotics four weeks prior to starting intervention 2.2. Use of prebiotics or probiotics (in other food products or as supplements) four weeks prior to starting intervention 2.3. Bowel preparation for a diagnostic procedure e.g. colonoscopy four weeks prior to starting intervention 2.4. Regular use of other supplements/medications that may affect the luminal microenvironment of the intestine (e.g. Orlistat, Lactulose)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expression of genes involved in immunity and inflammation in peripheral blood is measured using mRNA microarray to identify target genes and qPCR to quantify changes in gene expression, at baseline and 6 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| All secondary outcome measures will be assessed at baseline before the intervention begins and at the end of six weeks, blood, stool and urine samples will be collected at these two timepoints in order to assess the following: 1. Serum or plasma protein expression will be assessed using enzyme linked immunosorbent assays (ELISA) and standard blood laboratory techniques 2. Faecal markers of inflammation such as faecal calprotectin and human beta-defensin 2 will be measured using ELISA 3. Metabolomic profiles in urine are measured using mass spectrometric based approaches in urine metabolomics 4. Gut microbiota metabolites indicators including proteases, SCFAs, and VOC will be measured using standard laboratory techniques including gas liquid chromatography 5. pH will be measured on fresh stool using a solid probe pH meter 6. Bacterial communities and function will be measured via sequencing techniques | — |
Countries
England, United Kingdom
Contacts
Public ContactBridgette Wilson
Outcome results
None listed