Clinical Application of a Combined Lactulose H2-breath Test With Abdominal Imaging to Assess the Digestive Function: a Retrospective Cohort Study

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

Hydrogen (H₂) breath tests serve several purposes. (i) detect malabsorption of carbohydrates such as lactose and fructose, (ii) measurement of oro-caecal transit time (iii) associate hydrogen production with the onset of abdominal symptoms like bloating, flatulence, pain, and diarrhea (which indicates carbohydrate intolerance), and (iv) diagnose small intestinal bacterial overgrowth (SIBO). It is important to distinguish between carbohydrate intolerance and SIBO because their treatments differ significantly. Carbohydrate intolerance is typically managed through dietary restrictions, while SIBO requires antibiotic therapy. However, recent guidelines have questioned the accuracy of hydrogen breath tests in diagnosing SIBO due to variability in OCTT measurements. This limitation can be addressed by combining H₂ breath tests with imaging techniques such as scintigraphy, which independently confirm OCTT. When this combined approach is used, SIBO is diagnosed if the rise in breath H₂ occurs before the contrast agent appears in the large bowel. Despite its benefits, this combined method faces organizational and financial challenges that limit its routine clinical use. This retrospective cohort study aims to assess the clinical performance of a cheap and simple test that combines a 20g lactulose H₂ breath test with simple radiographic abdominal imaging to assess OCTT, SIBO, and carbohydrate tolerance. The novel innovation in this method is to confirm oro-caecal transit by taking an X-ray of the abdomen when H₂ production increases during the examination. If the contrast agent is not visible in the cecum when H₂ rises, this indicates the presence of SIBO. Conversely, if the contrast agent is present in the cecum at that time, it confirms normal OCTT, and any abdominal symptoms occurring after this point support a diagnosis of carbohydrate intolerance. If the method is proven to be valid, then this simple test will greatly facilitate the accurate diagnosis of SIBO and carbohydrate intolerance, allowing for more appropriate treatment decisions.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Switzerland
Klinik Arlesheim
RECRUITING
Arlesheim
Contact Information
Primary
Mark R Fox, MD
dr.mark.fox@gmail.com
+41791934795
Backup
Raik Hartwig, Dipl. med.
raik.hartwig@klinik-arlesheim.ch
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2026-12-31
Participants
Target number of participants: 500
Treatments
Patients referred for hydrogen breath testing
Adult patients referred for hydrogen breath testing between 2020 and 2024 were included in this cohort. All patients included in the analysis signed general consent for the use of anonymized clinical data in studies. Indications for investigation included assessment of causes of digestive symptoms or maldigestion. Patients had laboratory and other imaging or endoscopic investigations that showed no evidence of organic pathology.~This retrospective cohort study reports the performance of a combined 20g lactulose H2 breath test with radiographic abdominal imaging to assess OCTT, SIBO, and carbohydrate tolerance. The novel innovation in this method is to confirm OCTT by taking an X-ray of the abdomen when H2 production increases during the examination. If contrast agent is NOT visible in the caecum when H2 increases, then SIBO is present. Otherwise, if contrast agent is present in the caecum, then results confirm OCTT and carbohydrate intolerance.
Sponsors
Leads: Klinik Arlesheim
Collaborators: Kantonsspital Baselland Bruderholz

This content was sourced from clinicaltrials.gov