K63.8
Conditions
Interventions
Group 1: Non-interventional, prospective, single-arm exploratory study (Section 15 of the German Professional Code for Physicians [Berufsordnung für Ärzte, Bo-Ä]).
The investigation is conducted excl
any diagnostic assessment and therapeutic consequences remain solely the responsibility of the treating healthcare professional.
No changes are made to diagnosis or therapy.
Sponsors
VOC-Advanced Breath Diagnostics GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Written informed consent after receiving full information about the purpose and conduct of the study Clinical suspicion of SIBO with indication for a breath test (e.g., bloating, abdominal pain, diarrhea, or constipation) Ability and willingness to comply with test preparation (fasting, dietary restrictions, medication pause) and on-site testing
Exclusion criteria
Exclusion criteria: Antibiotic use within 4 weeks prior to testing Medications and procedures affecting test results: prokinetics, laxatives, opioids, bismuth, antacids within 1 week probiotics within 2 weeks bowel cleansing, colonoscopy, or enema within 4 weeks Acute gastrointestinal infection within 4 weeks Known conditions that may distort breath test results (short bowel syndrome, gastroparesis) Uncontrolled diabetes mellitus or other metabolic disorders Known glucose intolerance or contraindication to glucose Severe pulmonary disease or inability to provide standardized breath samples (e.g., advanced COPD) Active flare of chronic inflammatory bowel disease, uncontrolled celiac disease, or other severe uncontrolled gastrointestinal disease Pregnant or breastfeeding women (self-report and written confirmation); Participation in another interventional clinical study that could interfere with study results Any other condition which, in the investigator’s judgment, renders the participant unsuitable or at unreasonable risk.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of successfully collected and laboratory-analyzable breath samples (RUO-H2S system) relative to all planned/collected samples, reported as percentage with 95% confidence interval. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of subjects with negative or inconclusive H2/CH4 results who show elevated H2S levels (definition to be finalized) Statistical correlation (e.g., Pearson/Spearman) between gas profiles (H2, CH4, H2S) and gastrointestinal symptoms including 95% CI Descriptive analysis of observed H2S data trends to inform future study planning | — |
Countries
Germany
Contacts
Public ContactWieland Voigt
VOC-Advanced Breath Diagnostics GmbH
Outcome results
None listed