Clinical trial NCT02149043: Thermography in Surveillance of Ulcerative Colitis
Official title: Prototype Study on Association Between Clinical, Laboratory and Thermographic Findings in Patients With Ulcerative Colitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ulcerative Colitis
Keywords: Inflammatory bowel disease
Ulcerative Colitis
Thermography
Endoscopy
CRP
Fecal Calprotectin
Lead sponsor: University Hospital Dubrava
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will be recruited among active ulcerative colitis patients hospitalized in University Hospital Dubrava.

Healthy individuals matching sex and BMI to those of recruited ulcerative colitis patients.

Brief summary: Ulcerative colitis represents a chronic condition occurring in relapsing and remitting fashion with uncertain outcome and requires lifelong treatment with considerable side effects. Diagnostic methods currently in use, clinical (endoscopy), imaging (CT, MR) or laboratory (C - reactive protein, fecal calprotectin) give an insight into disease activity but are possibly associated with significant discomfort for the patient and / or increased risk of irradiation and potential allergic reactions on contrast agents. For that reason there is a need for a noninvasive, biologically inert method for evaluation of disease activity in inflammatory bowel disease (IBD). Thermography possesses most of these characteristics. The aim of this study is to find potential link between pathological thermographic signs and endoscopic findings, serum C reactive protein (CRP) and calprotectin in the stool of patients with active and extensive ulcerative colitis.

Detailed description: Hypothesis: Documenting pathological thermographic signs in patients with extensive ulcerative colitis investigators will demonstrate pathological thermography criteria that correlate with standard inflammatory markers such as Mayo endoscopic subscore (ESS), CRP and calprotectin in patients with ulcerative colitis.

Aims: The aim of this study is to record abdominal thermographic images of patients with active ulcerative colitis (UC), to create interpretational thermographic criteria for these images and to compare them to abdominal infrared (IR) images of healthy volunteers. Furthermore, investigators intend to correlate these criteria with standard markers of inflammation such as CRP and calprotectin in patients with UC at the beginning of treatment and at the end.

Materials and methods: For the purpose of this work, 36 patients with extensive UC and 30 healthy individuals will be put throe thermographic imagining, have their stool tested for calprotectin and their blood for CRP. In addition, patients with UC will receive colonoscopy evaluations.

Expected scientific contribution: The results of this paper would give an additional contribution to existing tools for pursuing ulcerative colitis activity thus demonstrating the potential of thermography as a complementary method to standard methods in assessing disease activity. Establishing diagnostic criteria for this method would be a good addition to present clinical practice.

Eligibility criteria: Inclusion Criteria:

* Endoscopic diagnosis of active extensive ulcerative colitis
* Stool Calprotectin \> 150 mcg/g
* CRP \> 5 mg/L
* Signed informed consent form

Exclusion Criteria:

* Inability to preform total colonoscopy
* Marked abdominal comorbidities
* Prior abdominal surgery

Primary outcomes:
measure: Change in abdominal surface temperatures in ulcerative colitis patients at 6 months
timeFrame: Six months
Secondary outcomes:
measure: Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.
timeFrame: Baseline and after 6 months
measure: Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.
timeFrame: Baseline and after 6 months
measure: Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.
timeFrame: Baseline and after 6 months
measure: Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.
timeFrame: Baseline and after 6 months
measure: Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.
timeFrame: Baseline and after 6 months
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Dubrava
Study officials:
affiliation: University Hospital Dubrava
name: Marko Banić, MD, PhD
role: STUDY_DIRECTOR
References:
citation: Banić M, et al. Thermography in patients with inflammatory bowel disease and colorectal cancer: evidence and review of the method. Periodicum biologorum 113(4): 439-444, 2011.
citation: Božin, Tonći, et al.
citation: Banić, Marko, et al.