Lactulose hydrogen breath testing combined with abdominal imaging
Clinical Application of a Combined Lactulose H2-breath Test With Abdominal Imaging to Assess the Digestive Function: a Retrospective Cohort Study
Klinik Arlesheim · NCT07145580
This project tests whether combining lactulose H2 breath testing with abdominal imaging helps clarify whether people referred for breath testing have carbohydrate malabsorption or small intestinal bacterial overgrowth (SIBO).
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Klinik Arlesheim (other) |
| Locations | 1 site (Arlesheim, Basel-Landschaft) |
| Trial ID | NCT07145580 on ClinicalTrials.gov |
What this trial studies
This is an observational project of patients referred for breath testing between 2020 and 2024 at Klinik Arlesheim, pairing lactulose H2 breath measurements with abdominal imaging (such as scintigraphy) to independently confirm oro-cecal transit time (OCTT). The combined approach is used to distinguish early H2 rises due to SIBO from those caused by rapid transit that can mimic SIBO on breath testing alone. The aims include detecting lactose/fructose malabsorption, measuring OCTT, and linking H2 production with onset of abdominal symptoms like bloating, pain, flatulence and diarrhea. Clinical data are used under general consent to explore whether imaging reduces false-positive SIBO diagnoses and better directs dietary versus antibiotic therapy.
Who should consider this trial
Good fit: Ideal candidates are patients referred for hydrogen breath testing for digestive symptoms (bloating, diarrhea, suspected carbohydrate intolerance or SIBO) who provided general consent for use of their clinical data and can attend Klinik Arlesheim.
Not a fit: People without relevant gastrointestinal symptoms, those not undergoing breath testing or abdominal imaging, or those unable to attend the study site are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, this approach could improve diagnostic accuracy so patients receive the right treatment—diet changes for malabsorption or antibiotics for true SIBO.
How similar studies have performed: Breath tests alone have shown variable accuracy and are questioned in recent guidelines, while prior work combining breath testing with scintigraphy or other imaging has suggested improved confirmation of OCTT in some cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients referred for breath testing to assess the causes of digestive symptoms or maldigestion 2020-2024 * Patients signed general consent to allow use of clinical data obtained during clinical assessment and breath testing to be used in research project. Exclusion Criteria: \-
Where this trial is running
Arlesheim, Basel-Landschaft
- Klinik Arlesheim — Arlesheim, Basel-Landschaft, Switzerland (RECRUITING)
Study contacts
- Study coordinator: Mark R Fox, MD
- Email: dr.mark.fox@gmail.com
- Phone: +41791934795
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Food Intolerance Syndromes, Small Intestinal Bacterial Overgrowth Syndrome, Breath Tests, Irritable bowel syndrome, Functional bloating, Functional Diarrhea, Small intestinal bacterial overgrowth syndrome, Hydrogen Breath Test