Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
66 participants
OBSERVATIONAL
2015-01-31
2018-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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.
Thermography
Thermographic imaging of the patient's abdomen surface
Colonoscopy
Endoscopic examination of the colon
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.
Thermography
Thermographic imaging of the patient's abdomen surface
Interventions
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Thermography
Thermographic imaging of the patient's abdomen surface
Colonoscopy
Endoscopic examination of the colon
Eligibility Criteria
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Inclusion Criteria
* Stool Calprotectin \> 150 mcg/g
* CRP \> 5 mg/L
* Signed informed consent form
Exclusion Criteria
* Marked abdominal comorbidities
* Prior abdominal surgery
18 Years
75 Years
ALL
Yes
Sponsors
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University Hospital Dubrava
OTHER
Responsible Party
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Tonći Božin
Gastroenterology Resident
Principal Investigators
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Marko Banić, MD, PhD
Role: STUDY_DIRECTOR
University Hospital Dubrava
Locations
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University Hospital Dubrava
Zagreb, , Croatia
Countries
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References
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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.
Božin, Tonći, et al.
Banić, Marko, et al.
Related Links
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University Hospital Dubrava
University of Zagreb
Other Identifiers
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THERMO-01
Identifier Type: -
Identifier Source: org_study_id
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