Plain English Summary
Background and study aims
Inflammatory bowel disease (IBD) is a group of common chronic disorders involving bowel inflammation. Ulcerative colitis and Crohn’s disease are the most important conditions of this group. IBD is usually diagnosed in young adults. In most cases it is characterized by long remissions and incidental flareups usually requiring treatment. Currently there are up to 600,000 IBD patients in the UK. All of them are at risk of a possible relapse. Those developing relapses are treated, and treatment efficiency assessment is an important task in need of serious improvements. In addition, IBD diagnosis is not straightforward since patients with functional conditions, such as extremely common irritable bowel syndrome (IBS) have similar symptoms. For this reason invasive endoscopy is usually applied in the absence of efficient non-invasive diagnostic methods. DiagNodus Ltd has developed a new method of non-invasive collection of biological material from the anal area following a natural bowel movement. This simple procedure based on sample self-collection provides a clear advantage compared to stool sample collection. The material collected using the new procedure contains cells in abundance and can be easily applied to a range of biomarker detection-based diagnostic and monitoring applications in the area of colorectal disease. This is an initial study looking at how well protein biomarker measurements in a group of patients with confirmed IBD and a parallel group of patients with IBS can help detect and treat IBD.
Who can participate?
Patients diagnosed with IBD and patients diagnosed with IBS
What does the study involve?
Participants are provided with material collection kits and instructed to self-collect samples of excreted material (rectal mucus containing cells and cell fragments with varying degrees of faecal contamination) from the external anal area immediately following defaecation using soft swabs. Material collections should be performed at home without any preparation or dietary or lifestyle restrictions. Following initial sample collection before the start of the treatment IBD patients undergo routine therapeutic treatments, and a range of selected protein biomarkers are quantitatively assessed in samples obtained using the new procedure both before treatment and at different times following the start of the treatment.
What are the possible benefits and risks of participating?
The results of this initial study should identify the most suitable protein biomarker(s) for developing a point of care (POC) test for IBD detection, treatment efficiency assessment and long-term monitoring of IBD activity.
Where is the study run from?
St George's Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2013 to July 2014
Who is funding the study?
DiagNodus Ltd (UK)
Who is the main contact?
Dr Alexandre Loktionov
alex.loktionov@diagnodus.com
Trial website
Contact information
Type
Scientific
Primary contact
Dr Alexandre Loktionov
ORCID ID
Contact details
DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
United Kingdom
+44 (0)1223 497 181
alex.loktionov@diagnodus.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
96543
Study information
Scientific title
Evaluation of a new method of noninvasive material collection for protein biomarker detection as an approach to assessing inflammatory bowel disease treatment efficiency.
Acronym
Study hypothesis
It is suggested that detection of protein biomarkers of colorectal disease in non-invasively collected samples of colorectal mucocellular layer can provide a highly efficient and convenient method of diagnosing inflammatory bowel disease (IBD) and assessing individual responses of patients to applied IBD therapy.
The trial addresses an important clinical problem of assessing therapy efficiency in patients developing flareups of inflammatory bowel disease (IBD). Tests based on the use of disease activity biomarkers are rarely applied for this purpose, detection of calprotectin in stool being the only test of this type sometimes used, but not widely clinically accepted. Introduction of inflammation biomarker detection in non-invasively obtained material can revolutionise IBD therapy efficiency assessment providing a convenient tool for checking therapeutic effects of applied drugs and individualising therapeutic schemes. Introduction of this approach into clinical practice can improve the cost efficiency of IBD treatment. An additional dimension of the trial is provided by comparing biomarker measurement results obtained in IBD patients with similar measurements done in subjects with irritable bowel syndrome (IBS) and healthy volunteers in order to assess IBD diagnosis efficiency.
Although this clinical trial involves biological material collection from patients, the proposed way of collecting biological samples for the study is absolutely non-invasive and not associated with any potential harm. All subjects agreeing to participate in the trial are provided with material collection kits and instructed to self-collect samples of excreted material (rectal mucus containing cells and cell fragments with varying degrees of faecal contamination) from the external anal area immediately following defaecation using soft swabs. All study participants are given written instruction sets and requested to sign informed consent forms. Material collections should be performed at home without any preparation or dietary or lifestyle restrictions.
All individual records used in the study are carefully anonymised and coded in order to avoid any possibility of personal identification of study participants.
Ethics approval
NRES Committee London - Queen's Square, 26/06/2012, ref: 12/LO/0237
Study design
Longitudinal and case-control designs
Primary study design
Observational
Secondary study design
Both longitudinal and case-control designs are applied within the study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Inflammatory bowel disease (IBD), irritable bowel syndrome (IBS)
Intervention
Although the study is basically observational, non-invasive collection (self-collection by study participants) of diagnostically informative samples is undertaken.
Intervention type
Other
Phase
Drug names
Primary outcome measures
1. Confirmation of sample collection method acceptance by patients
2. Confirmation of high quality of the collected material
3. Confirmation of the validity of biomarker quantification in the collected material for diagnostic and monitoring purposes
Secondary outcome measures
1. Selection of optimal biomarkers for IBD diagnosis
2. Selection of optimal biomarkers for IBD therapy efficiency assessment
Overall trial start date
16/01/2013
Overall trial end date
15/07/2014
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patients with active IBD requiring conservative treatment;
2. Patients with IBD in remission
3. Patients with IBS
4. Healthy volunteers (a smaller group)
Participant type
Mixed
Age group
Adult
Gender
Both
Target number of participants
120-200 (at least 120)
Participant exclusion criteria
1. Concomitant colorectal disease other than IBD or IBS
2. Extensive colorectal surgery in the past
Recruitment start date
16/01/2013
Recruitment end date
01/06/2014
Locations
Countries of recruitment
United Kingdom
Trial participating centre
DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
United Kingdom
Trial participating centre
St George's NHS Trust
Department of Gastroenterology
London
SW17 0QT
United Kingdom
Sponsor information
Organisation
DiagNodus Ltd
Sponsor details
Bldg 280
Babraham Research Campus
Cambridge
Cambridge
CB22 3AT
United Kingdom
+44 (0)1223 497 181
alex.loktionov@diagnodus.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Diagnodus Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
One conference presentation so far:
Chhaya, V, Poullis, A, Bandaletova, T, Loktionov, A. (2014). Patient acceptability of a novel, non-invasive method of colonic sampling for biomarker analysis. Gut, 63 (Suppl. 1) A131 (PWE-022).
Further conference presentations and journal publications planned in 2015-2016
Intention to publish date
01/08/2015
Participant level data
Not expected to be available
Results - basic reporting
Publication summary
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/27787913