NCT06177938 Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers
| NCT ID | NCT06177938 |
| Status | Recruiting |
| Phase | — |
| Sponsor | ETH Zurich |
| Condition | Lactose Intolerance |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-06-24 |
| Primary Completion | 2025-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-06-24 with a primary completion date of 2025-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion criteria: * 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 * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06177938 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Lactose Intolerance. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06177938 currently recruiting?
Yes, NCT06177938 is actively recruiting participants. Contact the research team at stamatios.giannoukos@org.chem.ethz.ch for enrollment information.
Where is the NCT06177938 trial being conducted?
This trial is being conducted at Zurich, Switzerland.
Who is sponsoring the NCT06177938 clinical trial?
NCT06177938 is sponsored by ETH Zurich. The trial plans to enroll 120 participants.