Lactobreath: Use of Breath Markers to Characterize Lactose Intolerance - A Pilot Study
Summary description of the study
This project aims to make the diagnosis of lactose intolerance simpler and faster. To achieve this, we will examine the exhaled air and analyze it with a special device. This is much quicker than the conventional methods we have used so far. We will recruit 120 healthy volunteers. Initially, we will check with some screening tests how they process lactose. One of the screening tests involves examining their genes using saliva samples. Before the study day, we will examine the participants' diet and analyze the composition of their feces to understand how their diet affects their gut. On the study day, we will give participants a lactose or glucose-containing drink (carbohydrate challenge) and observe them for 6 hours. During this time, we will collect breath, urine, and gastrointestinal gas samples. For this, we will use special sensors, including one that can be swallowed.
(BASEC)
Intervention under investigation
In this study, we will test two different carbohydrate drinks. One is a lactose drink containing 25 grams of lactose dissolved in 150 milliliters of water ("Intervention"), and the other is a glucose drink containing 13 grams of glucose dissolved in 150 milliliters of water ("Control").
We will conduct this test at the Department of Chemistry and Applied Biosciences at ETH Zurich. Before the test, participants must adhere to certain dietary guidelines for three days, and on the day of the test, they must not eat anything in the morning.
The test day will last 8 hours. It will begin with the collection of urine and breath samples from the participants. Additionally, we will ask them if they experience symptoms of lactose intolerance and check their overall health status.
Participants will be randomly assigned to one of the two drinks (lactose or glucose). After participants have consumed the assigned carbohydrate drink, they will immediately swallow a special capsule that can measure gases in the intestine. In the first 6 hours after the test begins, breath and urine samples will be taken, and we will continue to observe if symptoms of lactose intolerance occur.
(BASEC)
Disease under investigation
Food intolerances are common and can be managed through diet, but accurate diagnosis is crucial. Lactose intolerance is a common issue, and there are various tests, which are not always accurate. Some tests are invasive, and symptoms do not always match the results. Breath metabolomic analysis is a new way to investigate this. It is non-invasive and can analyze thousands of molecules that may change depending on what you eat and how your body processes food. This method is not yet widely used in nutrition but has potential. By examining the molecules in your breath, we can better understand food intolerances and how they work.
(BASEC)
1. At the time of the screening examination, aged between 18-65 years 2. Ability/willingness to provide informed consent and participate in the study procedures 3. Willingness to attend all study visits and complete all study-related procedures, including fasting before and during the intervention (BASEC)
Exclusion criteria
1. Allergic to milk 2. Diagnosed with a disease or disorder known to be associated with abnormal gastrointestinal motility, including gastroparesis, amyloidosis, neuromuscular diseases (including Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism 3. Swallowing difficulties or dysphagia for food or tablets/capsules (BASEC)
Trial sites
Zurich
(BASEC)
Sponsor
Dr Stamatios Giannoukos
(BASEC)
Contact
Contact Person Switzerland
Dr. Stamatios Giannoukos
+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.chETH Zürich, Department of Chemistry and Applied Biosciences
(BASEC)
General Information
+41 44 632 61 12;+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
General Information
+41 44 632 61 12+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
Scientific Information
+41 44 632 61 12;+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
31.10.2023
(BASEC)
ICTRP Trial ID
NCT06177938 (ICTRP)
Official title (approved by ethics committee)
Lactobreath: A pilot study to diagnose lactose intolerance based on the exhaled breath metabolome (BASEC)
Academic title
Lactobreath: a Pilot Study to Diagnose Lactose Intolerance Based on the Exhaled Breath Metabolome (ICTRP)
Public title
Lactobreath: a Study to Diagnose Lactose Intolerance Using Breath Markers (ICTRP)
Disease under investigation
Lactose Intolerance (ICTRP)
Intervention under investigation
Dietary Supplement: Lactose solution/Glucose solution (ICTRP)
Type of trial
Interventional (ICTRP)
Trial design
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Inclusion/Exclusion criteria
Inclusion criteria:
- Men and women
- Swiss and non-Swiss living in the Zurich area (if necessary, beyond Zrich in
Switzerland),
- Ability/desire to provide informed consent and partake in the procedures of the
study
- Aged 18-65 years at screening
- Agreement to refrain from all other treatments and products used for dairy
intolerance (e.g., Lactaid dietary supplements) during study involvement
- Willing to return for all study visits and complete all study-related procedures,
including fasting before and during the intervention
- Able to understand and provide written informed consent in English and/or German.
Exclusion criteria:
- Allergic to milk
- Currently pregnant
- Currently lactating
- Cigarette smoking or other use of tobacco or nicotine-containing products within 3
months of screening
- Diagnosed with any of the following disorders known to be associated with abnormal
GI motility: gastroparesis, amyloidosis, neuromuscular diseases (including
Parkinson's disease), collagen vascular diseases, alcoholism, uremia, malnutrition,
or untreated hypothyroidism
- History of surgery that alters normal GI tract function, including but not limited
to: GI bypass surgery, bariatric surgery, gastric banding, vagotomy, fundoplication,
pyloroplasty (N.B. history of uncomplicated abdominal or GI surgeries such as
removal of an appendix >12 months before screening will not be excluded)
- Suspected obscure GI bleeding
- Past or present: organ transplant, chronic pancreatitis, pancreatic insufficiency,
symptomatic biliary disease, coeliac disease, diverticular disease, inflammatory
bowel disease, strictures (suspected or known), fistulas, or any GI obstruction,
gastroparesis, history of gastric bezoar or any other medical condition with
symptoms that could confound collection of adverse events
- Diabetes mellitus
- Congestive heart failure
- Human immunodeficiency virus, hepatitis B, or hepatitis C
- Body mass index > 35 kg/m2
- Swallowing disorders or dysphagia to food or pills
- Presence of implantable or portable electro-mechanical medical devices (e.g.
pacemakers)
- Recent bowel preparation for endoscopic or radiologic investigation within 4 weeks
of screening (e.g., colonoscopy preparation)
- Chronic antacid and/or proton pump inhibitor use
- Recent use of systemic antibiotics, defined as use within 2 months prior to
screening
- History of ethanol (alcohol) and/or drug abuse in the past 12 months
- Patients with severe irritable bowel syndrome (IBS) (i.e., IBS Symptom Severity
Score >400)
- Dietary restrictions including vegan or vegetarian diet.
- Any other conditions/issues noted by the study staff and/or Principal Investigator
that would impact participation and/or protocol compliance.
- Previous enrollment in another clinical trial within the last 3 months.
- Results of the screening test showing GI symptoms in response to lactose ingestion
and genetic LP. (ICTRP)
not available
Primary and secondary end points
Diagnostic performance of the breath profile associated with lactose malabsorption (lactobreath profile) (ICTRP)
Urine metabolome;Metabolome of exhaled breath condensate (EBC) samples;Hydrogen breath test;Intestinal gases and GI transit assessment;Clinical symptoms of lactose intolerance (ICTRP)
Registration date
11.12.2023 (ICTRP)
Incorporation of the first participant
not available
Secondary sponsors
Agroscope Liebefeld-Posieux Research Station ALP;Swiss Allergy Centre;University of Zurich (ICTRP)
Additional contacts
Stamatios Giannoukos, PhD;Stamatios Giannoukos, Ph.D., stamatios.giannoukos@org.chem.ethz.ch, +41 44 632 61 12;+41 44 632 61 12 (ICTRP)
Secondary trial IDs
NEX_Lactobreath (ICTRP)
Results-Individual Participant Data (IPD)
not available
Further information on the trial
https://clinicaltrials.gov/ct2/show/NCT06177938 (ICTRP)
Results of the trial
Results summary
not available
Link to the results in the primary register
not available