Investigating the effects of resolving intestinal narrowing in Crohn’s disease – a study of gut bacteria, movement and products

Not Applicable

Completed

• Conditions: Crohn's Disease.; Digestive System

• Registration Number: ISRCTN14328524
• Lead Sponsor: niversity of Nottingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-20
• Study Completion: 2021-01-01
• Last Update Posted: 2 August 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 14

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> 1. The bowel microbiome will be measured using stool bascterial 16sRNA analysis pre-therapy, during therapy and post-therapy.<br> 2. Intestinal motility will be measured using magnetic resonance-assessed small bowel motility at baseline and after 6 weeks of therapy.<br> 3. The stool metabolic profile will be measured using gas-chromatography stool metabolomic analysis pre-therapy and post-therapy.<br> 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.<br>

Secondary Outcome Measures

Name	Time	Method
<br> 1. Progression onto Surgery<br> 2. Recruitment Rate<br> 3. Complications / Adverse Events<br>