Crohn's Disease
Conditions
Brief summary
This study evaluates the use of exhaled air analysis as tool to monitor the disease activity in Crohn's Disease (CD). This study is a validation of the previous findings. In this study the participant will be asked to donate exhaled air, blood samples and fecal samples. The breath samples will be used to measure various volatile metabolites in breath. The breath air will be next used to validate the previous findings. The blood samples will be used to define the origin of volatile metabolites in breath. Finally, the potential of exhaled breath analysis as non-invasive marker of diseases activity will be compared to established fecal calprotectin.
Detailed description
In the recent study(doi: 10.1097/Mib.0000000000000436) it was shown the potential of analysis of exhaled air to differentiate active and inactive state of Crohn's Disease (CD). Although, the molecules found in this cohort have shown potential to differentiate between CD patients in remission or with active disease, the validation of the outcomes has to be performed in new population. One crucial pathophysiologic factor in CD is excessive lipid peroxidation during oxidative stress, i.e. during overproduction of oxidants compared to the protective antioxidants. Oxidative stress is a potential aetiological factor and/or a triggering factor in CD. Many volatile compounds including hydrocarbons and aldehydes are produced during oxidative stress and they can be non-invasively measured in exhaled air 5, 6. However, exhaled breath contains volatile metabolites originating from previous or current uptake of environmental contaminants, and more interestingly from metabolism of foreign organisms (bacteria, viruses, fungi or yeasts). Therefore, it is important to study not only exhaled air but also blood in which blood borne volatile molecules can be measured. Since the current study also aims for validating the use of volatile molecules in exhaled air as non-invasive markers for disease activity in CD patients, the investigators will compare the outcome of exhaled air analysis with currently established non-invasive measure of disease activity, i.e. fecal calprotectin.
Interventions
OTHERSpecimen sampling
exhaled air samples blood samples fecal samples
Sponsors
Maastricht University
Dartmouth-Hitchcock Medical Center
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Age: 18-65 * BMI: 19-30 * scheduled colonoscopy
Exclusion criteria
* disease compromising immune system (such as HIV positive status or patients after organ transplantation * liver disease * active and untreated tuberculosis * chemotherapy agents
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Volatile organic compounds profile: volatile compound concentrations in breath | The samples will be collected within no more than one week before scheduled colonoscopy. | The exhaled air samples will be used to first validate the volatile compounds for disease activity in Crohn's Disease. |
| Metabolic profile: metabolite concentrations in blood | The samples will be collected within no more than one week before scheduled colonoscopy. | Blood samples will be used to better understand the origin of the volatile compounds in breath. |
| Fecal calprotectin (µg/g) in fecal samples | The samples will be collected within no more than one week before scheduled colonoscopy. | Fecal calprotectin will be measured as indicator of the migration of neutrophils to the intestinal mucosa. |
Countries
United States
Outcome results
None listed