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Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

NCT06177938 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-07-08

No results posted yet for this study

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.

Conditions

  • Lactose Intolerance

Interventions

DIETARY_SUPPLEMENT

Lactose solution/Glucose solution

Single ingestion of a lactose/glucose solution.

Sponsors & Collaborators

  • Agroscope Liebefeld-Posieux Research Station ALP

    collaborator OTHER

  • Swiss Allergy Centre

    collaborator UNKNOWN

  • University of Zurich

    collaborator OTHER

  • ETH Zurich

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-24
Primary Completion
2025-12-31
Completion
2025-12-31

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 NCT06177938 on ClinicalTrials.gov