Crohn's Disease. Digestive System
Conditions
Interventions
Patients with Crohn’s disease and abnormal intestinal ‘narrowings’ (known as ‘strictures’) will be asked to take part in the study. Each patient will have routine clinical treatment of their ‘strictu
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Crohn’s Disease as an established diagnosis (established diagnosis based on histology and supportive imaging) 2. Previous right hemicolectomy or partial resection and subsequent large and small bowel re-anastomosis 3. Identified anastomotic or de novo stricture accessible by colonoscopy – endoscopic or imaging identification (MR or CT or endoscopy) 4. Aged 16-80 years 5. Symptoms attributable to a focal ileocolonic stricture 6. Ability to give informed consent Inclusion into the study will only be following Inflammatory Bowel Disease Multidisciplinary Team referral and strict adherence to the given inclusion criteria.
Exclusion criteria
Exclusion criteria: 1. Malignancy 2. Significant cardiovascular or respiratory disease 3. Uncontrolled thyroid disease 4. Neurological or cognitive impairment 5. Significant physical disability 6. Hepatic disease or renal failure 7. Abnormal blood results other than those explained by CD in CD participants 8. Co-enrolment in other CD study 9. Pregnancy or ongoing breastfeeding 10. Any condition that precludes MRI scanning (e.g. pacemaker) 11. Routine usage of any medication that affects gastric emptying or small bowel motility (i.e. hyoscine butylbromide, mebeverine, domperidone, ondansetron, metoclopramide) 12. Inability to endoscopically access stricture or place stent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The bowel microbiome will be measured using stool bascterial 16sRNA analysis pre-therapy, during therapy and post-therapy. 2. Intestinal motility will be measured using magnetic resonance-assessed small bowel motility at baseline and after 6 weeks of therapy. 3. The stool metabolic profile will be measured using gas-chromatography stool metabolomic analysis pre-therapy and post-therapy. 4. Clinical impact on Crohn’s ileocolonic strictures will be measured using paired assessment with validated IBD scoring tools (CDAI, HBI, IBD-Q) at baseline and at 6-8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Progression onto Surgery 2. Recruitment Rate 3. Complications / Adverse Events | — |
Countries
England, United Kingdom
Contacts
Public ContactRonit Das
Outcome results
None listed