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Combined Lactulose H2-breath Test With Abdominal Imaging

NCT07145580 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2025-08-28

No results posted yet for this study

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.

Conditions

  • Food Intolerance Syndromes
  • Small Intestinal Bacterial Overgrowth Syndrome (SIBO)
  • Breath Tests

Sponsors & Collaborators

  • Kantonsspital Baselland Bruderholz

    collaborator OTHER

  • Klinik Arlesheim

    lead OTHER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-01
Primary Completion
2025-12-31
Completion
2026-12-31

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07145580 on ClinicalTrials.gov