Capsule Colonoscopy in Crohn's Disease and Its Correlation With Conventional Colonoscopy and Faecal Calprotectin

Study Purpose

Aims:

  • - To study the feasibility of capsule colonoscopy in patients with Crohn's Disease (CD).
  • - To compare the results of capsule colonoscopy with conventional colonoscopy in assessing mucosal healing.
  • - To correlate the level of faecal calprotectin with the results of capsule colonoscopy and conventional colonoscopy.
  • - To document changes in clinical practice attributable to the capsule colonoscopy findings a) concordant with and b) in addition to the parallel findings at colonoscopy and ileoscopy.
Project design: Cross sectional, prospective, comparative study Methodology: Patients of the Royal Melbourne Hospital (RMH) and other associated speciality clinics with an established diagnosis of CD who need assessment of mucosal healing and have consented to be part of the study will undergo capsule colonoscopy and conventional colonoscopy on the same day after undergoing bowel preparation. The images of both the conventional and capsule colonoscopies will be recorded. In addition calprotectin (an inflammatory marker in faeces) will be measured in a sample of faeces collected by the patients prior to the colonoscopy day. Professor Macrae and the scholarly selective student researcher will assess the recorded images obtained from capsule colonoscopies once the images have been deidentified. To assess the level of mucosal disease they will use the Simple Endoscopic Score for CD (SESCD). The results of the assessment of mucosal healing obtained from conventional colonoscopy will be compared with those of capsule colonoscopy and levels of faecal calprotectin will then be correlated.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Adults with established diagnosis of CD with ileal, colonic or ileo-colonic disease aged 18-75 years.
Gender: both male and female
  • - Patients of RMH IBD clinic and other specialty clinics where assessment of mucosal healing is clinically indicated this includes: Patients who have had Anti TNF induction therapy 6-12 months prior to commencement of this study AND/OR Patients referred for colonoscopy to assess mucosal disease status with a view to treatment escalation based on the findings.

Exclusion Criteria:

Patients must not: - Have known/suspected gastrointestinal obstruction - Have swallowing disorder - Have a known oesophageal stricture - Have severe gastroparesis - Have dementia - Have a cardiac pacemaker or other implanted medical device - Have sever cardiac or renal insufficiency - Have a previous allergy or contraindication to bowel preparation - Be pregnant - Prior major abdominal surgery - Colonoscopy is contraindicated

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02624414
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Melbourne Health
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Finlay Macrae
Principal Investigator Affiliation Melbourne Health
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherIndustry
Overall Status Recruiting
Countries Australia
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn's Disease
Arms & Interventions

Arms

Other: Anti TNF induction therapy 6-12 months

All subjects will be identified through The Royal Melbourne Hospital's IBD clinic, associated specialty clinics and the colonoscopy waiting list of The Royal Melbourne Hospital. The potential participants who have been commenced on Anti TNF induction therapy 6-12 months prior to commencement of the study will be identified. The potential participants identified in this way will be informed of the project at the time of contact and assessment; in some instances the potential participant will be informed of the project via telephone where subjects are remote. The potential participants will be provided an Ethically-approved information sheet at this time. Consent will be gained at the time of assessment.

Interventions

Device: - PillCamĀ® COLON 2 Capsule Endoscopy

Contact a Trial Team

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International Sites

Royal Melbourne Hospital, Parkville, Victoria, Australia

Status

Recruiting

Address

Royal Melbourne Hospital

Parkville, Victoria, 3050

Site Contact

Finlay Macrae

finlay.macrae@mh.org.au

+61393427580

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