Actively Recruiting
Clinical Application of a Combined Lactulose H2-breath Test With Abdominal Imaging to Assess Digestive Function in a Retrospective Cohort
Led by Klinik Arlesheim · Updated on 2025-08-28
500
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
K
Klinik Arlesheim
Lead Sponsor
K
Kantonsspital Baselland Bruderholz
Collaborating Sponsor
AI-Summary
What this Trial Is About
Hydrogen breath tests are used to detect carbohydrate malabsorption, measure the time it takes food to move through the intestines (oro-caecal transit time or OCTT), link hydrogen gas increases with abdominal symptoms like bloating and diarrhea, and diagnose small intestinal bacterial overgrowth (SIBO). Differentiating carbohydrate intolerance from SIBO is important because their treatments differ, with dietary changes used for intolerance and antibiotics for SIBO. Recent guidelines question the accuracy of hydrogen breath tests alone for diagnosing SIBO due to variable OCTT measurements, which can cause false positives. This study evaluates a new, simple, and affordable method combining a 20g lactulose hydrogen breath test with abdominal X-ray imaging to confirm OCTT and diagnose SIBO or carbohydrate intolerance. During the test, if hydrogen levels rise before the contrast agent appears in the cecum, SIBO is indicated. If the contrast agent is visible when hydrogen increases, OCTT is confirmed and symptoms after this point suggest carbohydrate intolerance. This approach aims to improve diagnosis without the higher costs and complexity of other imaging techniques. Participants included adults referred for hydrogen breath testing due to digestive symptoms with no organic disease found. During the test, breath hydrogen is monitored while abdominal X-rays are taken when hydrogen rises. Researchers will assess the safety and practicality of this combined test, measure agreement between observers analyzing OCTT, and determine the prevalence of food intolerance and SIBO among participants. The total assessment occurs within three hours during routine clinical care, using existing clinical data with patient consent.
CONDITIONS
Brief Title
Combined Lactulose H2-breath Test With Abdominal Imaging
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients referred for breath testing to assess digestive symptoms or maldigestion between 2020 and 2024
- Patients who have signed general consent allowing use of their clinical data for research
You will not qualify if you...
History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 hours
Participants undergo a combined 20g lactulose hydrogen breath test along with abdominal X-ray imaging to assess digestive function, including measuring oro-cecal transit time and detecting small intestinal bacterial overgrowth or carbohydrate intolerance.
1 visit (in-person)
Trial Site Locations
Total: 1 location
1
Klinik Arlesheim
Arlesheim, Basel-Landschaft, Switzerland, 4144
Actively Recruiting
Research Team
M
Mark R Fox, MD
R
Raik Hartwig, Dipl. med.
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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