Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort

Crohn's Disease Clinical Trial

Official title:

Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02641171
• Other study ID #: 00029059
• Status: Terminated
• Start date: December 2015
• Est. completion date: October 4, 2016

Study information

• Verified date: July 2018
• Source: Dartmouth-Hitchcock Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: October 4, 2016
• Est. primary completion date: October 4, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Other:
• Specimen sampling
exhaled air samples blood samples fecal samples

Locations

Country	Name	City	State
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (2)

Lead Sponsor	Collaborator
Dartmouth-Hitchcock Medical Center	Maastricht University

Country where clinical trial is conducted

United States, 

References & Publications (2)

Bodelier AG, Smolinska A, Baranska A, Dallinga JW, Mujagic Z, Vanhees K, van den Heuvel T, Masclee AA, Jonkers D, Pierik MJ, van Schooten FJ. Volatile Organic Compounds in Exhaled Air as Novel Marker for Disease Activity in Crohn's Disease: A Metabolomic — View Citation

Smolinska A, Hauschild AC, Fijten RR, Dallinga JW, Baumbach J, van Schooten FJ. Current breathomics--a review on data pre-processing techniques and machine learning in metabolomics breath analysis. J Breath Res. 2014 Jun;8(2):027105. doi: 10.1088/1752-7155/8/2/027105. Epub 2014 Apr 8. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volatile organic compounds profile: volatile compound concentrations in breath	The exhaled air samples will be used to first validate the volatile compounds for disease activity in Crohn's Disease.	The samples will be collected within no more than one week before scheduled colonoscopy.
Primary	Metabolic profile: metabolite concentrations in blood	Blood samples will be used to better understand the origin of the volatile compounds in breath.	The samples will be collected within no more than one week before scheduled colonoscopy.
Primary	Fecal calprotectin (µg/g) in fecal samples	Fecal calprotectin will be measured as indicator of the migration of neutrophils to the intestinal mucosa.	The samples will be collected within no more than one week before scheduled colonoscopy.