IBDVOCNCT04827368
Volatile Organic Compounds (VOCs) in Active Inflammatory Bowel Disease
An observational study of IBD and Crohn Disease, run by The Cleveland Clinic at 1 site in United States.
Trial summary
Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- IBD, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Breath Test
- How many people
- 292 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Mar 2021to 30 Jun 2026
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines. At inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.
Who may be able to join
- Diagnosed as having Crohn's Disease or Ulcerative Colitis
- Aged 18-70 years.
- Understands the language and signs an informed consent form.
- Any disease location, except isolated upper GI Crohn's disease only
- Any CD or UC disease activity.
- Outpatients and inpatients
- Patients will be recruited, and samples obtained at least one day, and no more than one week, prior to out/inpatient colonoscopy preparation to allow objective assessment of disease activity.
Who cannot join
- Status post colectomy
- Status post diverting loop ileostomy or end ileostomy or colostomy
- On antibiotics in the past 3 months or currently
- Women (pregnant or breast feeding)
- Subjects with concurrent chronic liver, renal, lung or metabolic disorders
- Active malignancy
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- Bowel preparation at day of sample procurement
- Isolated upper GI Crohn's disease only
- Active disease on colonoscopy, but normal fecal calprotectin at inclusion
- C diff. positive at time of inclusion (test to be obtained in routine clinical care).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds
Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.
- Conditions
- IBD, Crohn Disease, Ulcerative Colitis
- Being tested
- Breath Test
- Keywords
- IBD, VOC
- Medical subject headings
- Crohn Disease, Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breath TestOther
Also called Serum Samples, Stool Samples
Research Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers.
| Study group | Role | What they receive |
|---|---|---|
| Crohns Disease | Potential participants will be identified based on their planned/scheduled endoscopy visit. Receives: Other: Breath Test | |
| Ulcerative Colitis | Potential participants will be identified based on their planned/scheduled endoscopy visit. Receives: Other: Breath Test | |
| Non-IBD | Healthy subjects with no bowel disorders will be included as controls. Receives: Other: Breath Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity
Correlation of breath VOCs with changes in Fecal Calprotectin.
Measured: 1 year
Secondary outcomes (1)
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity
Correlation of breath VOCs with changes in C-reactive protein (CRP) and clinical disease activity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start22 Mar 2021
- Primary completion30 Jun 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IBDStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Florian Rieder, The Cleveland Clinic
- Investigators
- Florian Rieder, MD, Principal investigator, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04827368
- Sponsor's protocol ID
- 20-1149
- Other IDs
- B19-566
- Acronym
- VOC
- Status last verified
- Aug 2026
- First submitted
- 30 Mar 2021
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-invasive Disease Activity Monitoring in Patients With Inflammatory Bowel Disease (IBD) Using Volatile Organic Compounds
- ClinicalTrials.gov ID
- NCT04827368
- Acronym / sponsor ID
- VOC / 20-1149
- Conditions
- IBD, Crohn Disease, Ulcerative Colitis
- Keywords
- IBD, VOC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 22 Mar 2021 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 1 Apr 2021 (actual)
- 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.
Inflammatory Bowel Disease (IBD) are chronic diseases of the gut comprising Crohn's Disease (CD) and Ulcerative Colitis (UC). The symptoms of IBD consist of diarrhea, abdominal discomfort, weight loss, fatigue and rectal bleeding. However, symptoms and treatment vary between patients. Early management of IBD can lead to better response rates and decrease the risk of irreversible bowel damage and future disease complications such as surgeries. Current clinical tools for diagnosis and or assessing progression of IBD are either invasive (colonoscopy), have low patient acceptance (fecal calprotectin) or low accuracy (C-reactive protein). The purpose of this study is to collect clinical data and samples (including blood, breath and stool) donated by patients with IBD and patients with no IBD (controls) to facilitate research that may result in the development of new non-invasive methods of diagnosing IBD and understand the progression of the disease over time in order to better manage IBD patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Crohns Disease | – | Other: Breath TestPotential participants will be identified based on their planned/scheduled endoscopy visit. |
| Ulcerative Colitis | – | Other: Breath TestPotential participants will be identified based on their planned/scheduled endoscopy visit. |
| Non-IBD | – | Other: Breath TestHealthy subjects with no bowel disorders will be included as controls. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This is a prospective, controlled, non-interventional cohort study, conducted at the Cleveland Clinic IBD Center, using serially obtained breath and serum headspace VOCs as non-invasive biomarkers to detect disease activity in IBD, fecal calprotectin, CRP, and patient-reported outcome tools. No drug will be evaluated in this study. All visits for this study as well as the initial endoscopy will be based on standard clinical practice and guidelines. At inclusion, all patients will have a colonoscopy (indication is standard of care), CRP, fecal calprotectin, and baseline PRO2 to establish the pattern for disease activity, which will subsequently be evaluated for change by using fecal calprotectin, CRP, and PRO2 over one year (every 3 months), as a surrogate marker for disease activity.
Key inclusion criteria (7 listed)
- Diagnosed as having Crohn's Disease or Ulcerative Colitis
- Aged 18-70 years.
- Understands the language and signs an informed consent form.
- Any disease location, except isolated upper GI Crohn's disease only
- Any CD or UC disease activity.
Key exclusion criteria (10 listed)
- Status post colectomy
- Status post diverting loop ileostomy or end ileostomy or colostomy
- On antibiotics in the past 3 months or currently
- Women (pregnant or breast feeding)
- Subjects with concurrent chronic liver, renal, lung or metabolic disorders
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 |
|---|---|---|
| Breath TestAlso: Serum Samples, Stool SamplesResearch Breath sample through disposable mouth filter. Serum sample through routine blood draw. Stool sample through standard collection containers. | Other | Crohns Disease, Non-IBD, Ulcerative Colitis |
Primary outcome
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity
Time frame: 1 year
Correlation of breath VOCs with changes in Fecal Calprotectin.
1 secondary outcome
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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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.
Florian Rieder, MD principal investigator
The Cleveland Clinic
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 IBD and Crohn Disease, run by The Cleveland Clinic 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 7 inclusion and 10 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: finished, as of the sponsor's last update on 31 Aug 2026. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Breath volatile organic compounds (VOC)s and objective markers of Inflammatory Bowel Disease (IBD) Activity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Aug 2026.