Actively Recruiting

Age: 18Years +
All Genders
ID07145580

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

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

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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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