Breath Test for Inflammatory Bowel Disease
(VOC Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to explore new, non-invasive methods to diagnose and understand the progression of Inflammatory Bowel Disease (IBD), including Crohn's Disease and Ulcerative Colitis. Researchers collect samples such as breath, blood, and stool from individuals with IBD and healthy participants to gather important data. The trial includes a simple breath test, known as the Acetaldehyde Breath Test, which could lead to better and less invasive diagnostic methods. Individuals diagnosed with Crohn's or Ulcerative Colitis who have a colonoscopy planned might be suitable for this study. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve diagnostic methods for IBD.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are on antibiotics, you cannot participate if you've taken them in the past 3 months or are currently taking them.
What prior data suggests that this Breath Test is safe for diagnosing IBD?
Research has shown that breath tests, which measure certain chemicals in the breath, hold promise for diagnosing inflammatory bowel disease (IBD). These tests can identify patterns that distinguish IBD from other conditions. Notably, this method is non-invasive, requiring no surgery or needles.
Breath tests are considered very safe and easy to administer, as they only require breathing into a device. No major side effects have been reported, making them a suitable option for those concerned about discomfort or side effects.
Although specific safety data for this exact test is not available, its non-invasive nature suggests it poses a low risk. For those considering participation in a trial using this method, the likelihood of harm is very low.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel way to detect active inflammatory bowel disease (IBD) through a breath test, focusing on volatile organic compounds (VOCs). Unlike traditional methods like colonoscopy or stool tests, this breath test offers a non-invasive, quick, and potentially more comfortable alternative for patients. The breath test could provide faster results, helping doctors to monitor and manage conditions like Crohn’s disease and ulcerative colitis more efficiently. If successful, this could transform how IBD is diagnosed and monitored, offering patients a less intrusive option.
What evidence suggests that the Breath Test is effective for diagnosing IBD?
Research has shown that certain chemicals in breath, known as volatile organic compounds (VOCs), can help identify inflammation in individuals with inflammatory bowel disease (IBD). Some studies have found that specific patterns of these chemicals can distinguish between inflammation caused by IBD and other health issues. The trial will include separate arms for participants with Crohn's Disease, Ulcerative Colitis, and healthy controls. Certain VOCs appear unique to conditions like Crohn's Disease and Ulcerative Colitis. This suggests that breath tests might offer a simple, non-invasive way to diagnose or monitor IBD. However, further research is needed to confirm these findings and enhance test accuracy.46789
Who Is on the Research Team?
Florian Rieder, MD
Principal Investigator
The Cleveland Clinic
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Sample Collection
Collection of clinical data and samples including blood, breath, and stool from patients with IBD and controls
Follow-up
Participants are monitored for safety and effectiveness after sample collection
What Are the Treatments Tested in This Trial?
Interventions
- Breath Test
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Potential participants will be identified based on their planned/scheduled endoscopy visit.
Healthy subjects with no bowel disorders will be included as controls.
Potential participants will be identified based on their planned/scheduled endoscopy visit.
Find a Clinic Near You
Who Is Running the Clinical Trial?
The Cleveland Clinic
Lead Sponsor
AbbVie
Industry Sponsor
Dr. Roopal Thakkar
AbbVie
Chief Medical Officer since 2023
MD from Wayne State University School of Medicine
Robert A. Michael
AbbVie
Chief Executive Officer
Bachelor's degree in Finance from the University of Illinois
Citations
Metabolomic analysis of breath volatile organic ...
No significant difference in VOCs was found between patients with Crohn's disease or ulcerative colitis and no significant correlation was seen with disease ...
Pentane and other volatile organic compounds, including ...
A study has been carried out on the volatile organic compounds (VOCs) in the exhaled breath of patients suffering from inflammatory bowel disease (IBD)
3.
researchgate.net
researchgate.net/publication/280033316_Analysis_of_Exhaled_Breath_Volatile_Organic_Compounds_in_Inflammatory_Bowel_Disease_A_Pilot_Study(PDF) Analysis of Exhaled Breath Volatile Organic ...
Analysis of Exhaled Breath Volatile Organic Compounds in Inflammatory Bowel Disease: A Pilot Study. June 2015; Journal of Crohn s and Colitis 9( ...
Breath Analysis Using eNose and Ion Mobility Technology ...
In recent years, numerous studies have investigating the efficacy of breath VOCs to diagnose IBD [16,44,45]. At least three studies utilised ...
Are Volatile Organic Compounds Accurate Markers in the ...
Some VOC profiles, besides identifying inflammation, seem disease-specific in inflammatory bowel diseases. Thus, breath, urine, and fecal VOCs provide a new ...
A Distinct Colon-Derived Breath Metabolome is Associated ...
CONCLUSIONS: A specific breath metabolome is associated with IBD and markedly changes in patients with IPAA. Analysis of a broader spectrum of ...
Breathing new life into clinical testing and diagnostics
Breath biomarkers associated with specific metabolic processes can offer direct readouts of disease activity and treatment response [Citation12]. For example, ...
Alcohol Use in Patients With Inflammatory Bowel Disease
Moreover, alcohol use also has been shown to negatively impact outcomes of hospitalized patients with IBD, including increased intestinal infections, need for ...
Prospect and Challenges of Volatile Organic Compound ...
The objective of this review is to explore the potential of VOC breath tests for the diagnosis of non-cancer diseases.
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