Crohn's DiseaseNCT02641171
Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort
An observational study of Crohn's Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Specimen sampling
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2015to 4 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age: 18-65
- BMI: 19-30
- scheduled colonoscopy
Who cannot join
- disease compromising immune system (such as HIV positive status or patients after organ transplantation
- liver disease
- active and untreated tuberculosis
- chemotherapy agents
Trial locations and contacts
1 site in 1 country.
United States1 site
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03766
About this study
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.
Read the 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.
- Conditions
- Crohn's Disease
- Being tested
- Specimen sampling
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimen samplingOther
exhaled air samples blood samples fecal samples
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Specimen sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: The samples will be collected within no more than one week before scheduled colonoscopy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startDec 2015
- Primary completion4 Oct 2016
- Study completion4 Oct 2016
Why it stopped: Too slow recruitment and no staff availability
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Dartmouth-Hitchcock Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dartmouth-Hitchcock Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Maastricht University
- Responsible party
- Principal investigator, Agnieszka Smolinska, Maastricht University
- Investigators
- Agnieszka Smolinska, PhD, Principal investigator, Dartmouth/Maastricht UniversityCorey A Siegel, PhD,MD, Principal investigator, Dartmouth-Hitchcock Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02641171
- Sponsor's protocol ID
- 00029059
- Status last verified
- Jul 2018
- First submitted
- 10 Dec 2015
- Last updated
- 12 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
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.
PubMed 24713999Bodelier 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.
PubMed 26199990
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volatiles in Exhaled Breath and Blood in Crohn's Disease: Validation Cohort
- ClinicalTrials.gov ID
- NCT02641171
- Acronym / sponsor ID
- 00029059
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Too slow recruitment and no staff availability
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Dartmouth-Hitchcock Medical CenterUniversity, hospital or other
- Collaborators
- Maastricht University
- Study start
- Dec 2015 (actual)
- Primary completion
- 4 Oct 2016 (actual)
- Study completion
- 4 Oct 2016 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Entire Cohort | – | Other: Specimen samplingThis is an observational/validation study and there is no intervention involved. Exhaled air samples, blood samples, and fecal samples will be obtained. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Age: 18-65
- BMI: 19-30
- scheduled colonoscopy
Key exclusion criteria (4 listed)
- disease compromising immune system (such as HIV positive status or patients after organ transplantation
- liver disease
- active and untreated tuberculosis
- chemotherapy agents
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specimen samplingexhaled air samples blood samples fecal samples | Other | Entire Cohort |
Primary outcome
Volatile organic compounds profile: volatile compound concentrations in breath
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
The study was stopped early (reason given: Too slow recruitment and no staff availability). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2018.
- Background: PubMed 24713999Smolinska 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.
- Results publication: PubMed 26199990Bodelier 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Agnieszka Smolinska, PhD principal investigator
Dartmouth/Maastricht University
Corey A Siegel, PhD,MD principal investigator
Dartmouth-Hitchcock Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Dartmouth-Hitchcock Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Too slow recruitment and no staff availability). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Volatile organic compounds profile: volatile compound concentrations in breath (time frame: The samples will be collected within no more than one week before scheduled colonoscopy.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02641171, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2018.