Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers
ConditionLactose Intolerance
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorETH Zurich
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Men and women
Swiss and non-Swiss living in the Zurich area (if necessary, beyond Zürich in Switzerland),
Ability/desire to provide informed consent and partake in the procedures of the study
Aged 18-65 years at screening
Disqualifiers
Allergic to milk
Currently pregnant
Currently lactating
Cigarette smoking or other use of tobacco or nicotine-containing products within 3 months of screening
Trial design
Design model
Parallel
Treatments tested in this trial
Lactose solution/Glucose solution
Dietary supplementSingle ingestion of a lactose/glucose solution.
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: Lactose solutionExperimental treatment 1 intervention
Group B: Glucose solutionPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Diagnostic performance of the breath profile associated with lactose malabsorption (lactobreath profile)
Selected metabolites identified from exhaled breath after lactose intake that can collectively discriminate clinical traits associated with lactose malabsorption. Several parameters with be assessed: sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), the likelihood ratio of a positive test (LR+), the likelihood ratio of a negative test (LR-).
Time frame
Breath samples will be collected at 9 time points following the ingestion of lactose (15 min, 30 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, and 360 min).Secondary outcomes
1
Urine metabolome
Metabolites identified in urine samples using GC-qTOF (including lactose and its metabolites, galactose, galactitol, and galactonate).
Time frame
Two pooled postprandial timepoints following lactose intake (0-3h and 3-6h)2
Metabolome of exhaled breath condensate (EBC) samples
Metabolites identified in EBC samples using standardized LC-MS methods (reversed-phase and HILIC) and GC-MS.
Time frame
9 postprandial timepoints following lactose intake (15 min, 30 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, and 360 min)3
Hydrogen breath test
Dynamic assessment of the hydrogen in breath after dietary exposure using hydrogen breath sensor
Time frame
9 postprandial timepoints following lactose intake (15 min, 30 min, 60 min, 90 min, 120 min, 180 min, 240 min, 300 min, and 360 min)4
Intestinal gases and GI transit assessment
Dynamic assessment of the environment of the intestine via a commercial gas-sensing capsule to evaluate intestinal gas concentrations (H2, O2, CO2, and CH4), pH and GI transit.
Time frame
Semi-continuous (every 20 seconds) postprandial assessment following lactose intake until excretion of the capsuleSponsors and contacts
Click on the lead sponsor to view all of their trials.
ETH Zurich
Lead sponsor
Agroscope Liebefeld-Posieux Research Station ALP
Collaborator
Swiss Allergy Centre
Collaborator
University of Zurich
Collaborator
Source ClinicalTrials.gov