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

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.

Study Overview

• Status: Terminated
• Conditions: Crohn's Disease
• Intervention / Treatment: Other: Specimen sampling

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• United States
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03766
      • Dartmouth Hitchcock Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Our target population will consist of individuals with established diagnosis of Crohn's Disease (CD). The target population will include male and female between the ages of 18 and 65 years and standard BMI (between 19 and 30). Potential study participants will be excluded if having any disease compromising immune system (such as HIV positive status or patients after organ transplantations), diagnosis of any liver disease, active and untreated tuberculosis and chemotherapy agents. All potential participants must have scheduled appointment for colonoscopy.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Entire Cohort; This is an observational/validation study and there is no intervention involved. Exhaled air samples, blood samples, and fecal samples will be obtained.	Other: Specimen sampling; exhaled air samples blood samples fecal samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.
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.

Collaborators and Investigators

• Sponsor: Dartmouth-Hitchcock Medical Center
• Collaborators: Maastricht University
• Investigators: Principal Investigator: Agnieszka Smolinska, PhD, Dartmouth/Maastricht University; Principal Investigator: Corey A Siegel, PhD,MD, Dartmouth-Hitchcock Medical Center

Publications and helpful links

General Publications

• 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.
• 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 Approach. Inflamm Bowel Dis. 2015 Aug;21(8):1776-85. doi: 10.1097/MIB.0000000000000436.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2015
• Primary Completion (Actual): October 4, 2016
• Study Completion (Actual): October 4, 2016

Study Registration Dates

• First Submitted: December 10, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 29, 2015

Study Record Updates

• Last Update Posted (Actual): July 12, 2018
• Last Update Submitted That Met QC Criteria: July 10, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 00029059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No