Condition category
Digestive System
Date applied
21/12/2014
Date assigned
12/01/2015
Last edited
12/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 (London).

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

Dr Alexandre Loktionov
DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
Cambridge
CB22 3AT
United Kingdom
+441223497181
alex.loktionov@diagnodus.com

Type

Public

Additional contact

Dr Alexandre Loktionov

ORCID ID

Contact details

Dr Alexandre Loktionov
DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
Cambridge
CB22 3AT
United Kingdom
+441223497181
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, 26/06/12, 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 below 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

Patient

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
DiagNodus Ltd Bldg 280 Babraham Research Campus Cambridge CB22 3AT
Cambridge
CB22 3AT
United Kingdom

Trial participating centre

Department of Gastroenterology, St George's NHS Trust
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

DiagNodus Ltd

Sponsor details

DiagNodus Ltd
Bldg 280
Babraham Research Campus
Cambridge
CB22 3AT
Cambridge
CB22 3AT
United Kingdom
+441223497181
alex.loktionov@diagnodus.com

Sponsor type

Industry

Website

www.diagnodus.com

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 methodof 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

Publication citations

Additional files

Editorial Notes