Lactobreath: Use of Breath Markers to Characterize Lactose Intolerance - A Pilot Study
Descrizione riassuntiva dello studio
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)
Intervento studiato
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)
Malattie studiate
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)
Criteri di esclusione
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)
Luogo dello studio
Zurigo
(BASEC)
Sponsor
Dr Stamatios Giannoukos
(BASEC)
Contatto per ulteriori informazioni sullo studio
Persona di contatto in Svizzera
Dr. Stamatios Giannoukos
+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.chETH Zürich, Department of Chemistry and Applied Biosciences
(BASEC)
Informazioni generali
+41 44 632 61 12;+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
Informazioni generali
+41 44 632 61 12+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
Informazioni scientifiche
+41 44 632 61 12;+41 44 632 61 12
stamatios.giannoukos@clutterorg.chem.ethz.ch(ICTRP)
Nome del comitato etico approvante (per studi multicentrici solo il comitato principale)
Commissione etica Zurigo
(BASEC)
Data di approvazione del comitato etico
31.10.2023
(BASEC)
ID di studio ICTRP
NCT06177938 (ICTRP)
Titolo ufficiale (approvato dal comitato etico)
Lactobreath: A pilot study to diagnose lactose intolerance based on the exhaled breath metabolome (BASEC)
Titolo accademico
Lactobreath: a Pilot Study to Diagnose Lactose Intolerance Based on the Exhaled Breath Metabolome (ICTRP)
Titolo pubblico
Lactobreath: a Study to Diagnose Lactose Intolerance Using Breath Markers (ICTRP)
Malattie studiate
Lactose Intolerance (ICTRP)
Intervento studiato
Dietary Supplement: Lactose solution/Glucose solution (ICTRP)
Tipo di studio
Interventional (ICTRP)
Disegno dello studio
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Triple (Participant, Investigator, Outcomes Assessor). (ICTRP)
Criteri di inclusione/esclusione
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)
non disponibile
Endpoint primari e secondari
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)
Data di registrazione
11.12.2023 (ICTRP)
Inclusione del primo partecipante
non disponibile
Sponsor secondari
Agroscope Liebefeld-Posieux Research Station ALP;Swiss Allergy Centre;University of Zurich (ICTRP)
Contatti aggiuntivi
Stamatios Giannoukos, PhD;Stamatios Giannoukos, Ph.D., stamatios.giannoukos@org.chem.ethz.ch, +41 44 632 61 12;+41 44 632 61 12 (ICTRP)
ID secondari
NEX_Lactobreath (ICTRP)
Risultati-Dati individuali dei partecipanti
non disponibile
Ulteriori informazioni sullo studio
https://clinicaltrials.gov/ct2/show/NCT06177938 (ICTRP)
Risultati dello studio
Riepilogo dei risultati
non disponibile
Link ai risultati nel registro primario
non disponibile