Thermography in Surveillance of Ulcerative Colitis

NCT02149043 | Completed

• 1 other identifier: THERMO-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Ulcerative Colitis

Keywords

Inflammatory bowel disease; Ulcerative Colitis; Thermography; Endoscopy; CRP; Fecal Calprotectin

Outcome Measures

Primary Outcomes (1)

• Change in abdominal surface temperatures in ulcerative colitis patients at 6 months

  Patients will be treated with mesalamin, corticosteroids or biologic therapy according to disease status during 6 months. Abdominal temperatures (maximal, minimum and average temperatures measured in Celsius) recorded by a thermographic camera will be acquired at enrollment and after 6 months of therapy.

  Six months

Secondary Outcomes (5)

• Correlation of abdominal surface temperatures between ulcerative colitis patients and healthy volunteers.

  Baseline and after 6 months

• Correlation of abdominal surface temperature values with clinical markers of inflammation in ulcerative colitis.

  Baseline and after 6 months

• Correlation of abdominal surface temperature values with fecal markers of inflammation in ulcerative colitis.

  Baseline and after 6 months

• Correlation of abdominal surface temperature values with serum markers of inflammation in ulcerative colitis.

  Baseline and after 6 months

• Correlation of abdominal surface temperature values with endoscopic markers of inflammation in ulcerative colitis.

  Baseline and after 6 months

Study Arms (2)

Ulcerative Colitis patients

30 patients with active ulcerative colitis will be put throe thermography and colonoscopy. Their stool will be tested for fecal calprotectin and their blood for CRP and other laboratory measures.

Device: Thermography; Procedure: Colonoscopy

Healthy volunteers

30 healthy individuals matching sex and BMI to those of ulcerative colitis patients will be put throe thermography and have their stool tested for fecal calprotectin and their blood for CRP.

Device: Thermography

Interventions

Thermography DEVICE

Thermographic imaging of the patient's abdomen surface

Healthy volunteers; Ulcerative Colitis patients

Colonoscopy PROCEDURE

Endoscopic examination of the colon

Ulcerative Colitis patients

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Dubrava: lead

Study Sites (1)

University Hospital Dubrava

Zagreb, 10000, Croatia

Location

Related Publications (3)

• 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.

  BACKGROUND

• Božin, Tonći, et al.

  BACKGROUND

• Banić, Marko, et al.

  BACKGROUND

Related Links

• University Hospital Dubrava
• University of Zagreb

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples for fecal calprotectin concentration measurements.

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Thermography; Colonoscopy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Thermometry; Investigative Techniques; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Marko Banić, MD, PhD

  University Hospital Dubrava

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gastroenterology Resident

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 29, 2014
• Study Start: January 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

CR (1)