Clinical Trial

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

Study acronym: Lactobreath
Recruiting
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Record status
This record was last updated July 8, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.
Summary
Food intolerances affect many people and can cause discomfort and dietary challenges. One common cause is difficulty digesting certain carbohydrates called FODMAPs. Diagnosing food intolerance is often done by excluding and then slowly reintroducing these carbohydrates or using a hydrogen breath test, but these methods have limitations. To address these issues, this project uses the breath we exhale to find markers for lactose intolerance as a model for food intolerance diagnosis. Our aim is to identify breath markers for lactose tolerance and intolerance and link them to metabolic traits, including those found in urine. We use a real-time breath analysis method and a special sensor to measure gases in the digestive system, and we also explore genetic factors using saliva samples. This project aims to help clinicians better identify patients who should follow low FODMAP diets and provide non-invasive breath tests to predict how patients will respond to these diets. It will also advance the use of breath analysis for personalized nutrition, contributes to the broader field of food intolerance research, and has the potential to benefit millions of individuals worldwide.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2023-12-11; most recent amendment 2025-07-02.
Status change: Not Yet Recruiting → Recruiting 2024-01-25
Trial Details
NCT Number NCT06177938
Lead Sponsor ETH Zurich
Collaborators: Agroscope Liebefeld-Posieux Research Station ALP, Swiss Allergy Centre, University of Zurich
Conditions Lactose Intolerance
Enrollment 120 participants
Start Date 2024-06-24
Primary Completion 2025-12 (estimated)
Study Completion 2025-12 (estimated)
Updated on ClinicalTrials.gov 2025-07-08