What is this study trying to find out about lactose intolerance?

This study aims to identify markers in exhaled breath that can help diagnose lactose intolerance more effectively. Researchers are exploring how breath analysis and genetic factors relate to lactose tolerance and symptoms. This research may help develop better non-invasive tests and guide personalized dietary advice for people with food intolerances.

Who may be eligible for this lactose intolerance clinical trial?

Adults aged 18 to 65 who can provide informed consent and are willing to follow study procedures may be eligible. Participants must not have milk allergies, pregnancy, or recent tobacco use and must agree to avoid other dairy intolerance treatments during the study. Please review eligibility criteria for more details.

Is there any cost to participate in this lactose intolerance clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any travel costs.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 65Years

All Genders

Healthy Volunteers

ID06177938

Lactobreath Using Breath Analysis to Diagnose Lactose Intolerance A Pilot Study with Genetic and Metabolic Screening in Adults Aged 18 to 65

Led by ETH Zurich · Updated on 2025-07-08

120

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Research is investigating lactose intolerance, a common food intolerance caused by difficulty digesting certain carbohydrates called FODMAPs. Existing diagnosis methods like exclusion diets or hydrogen breath tests have limitations. This study aims to identify breath markers linked to lactose tolerance and intolerance, using lactose intolerance as a model to improve diagnosis and personalize nutrition. It also explores genetic factors and metabolic traits from urine samples to help guide low FODMAP dietary recommendations. Participants will undergo a home lactose tolerance screening using a lactose powder test and saliva collection for genetic analysis. Based on their genetic profiles and symptoms, 120 participants will be divided into three groups. They will consume either a lactose or glucose solution in a randomized, triple-blind setup, swallowing a gas-sensing capsule to monitor intestinal gases. Several biological samples will be collected before and up to six hours after ingestion, including breath, breath condensate, urine, and symptom questionnaires. Participants will complete dietary recalls and provide fecal samples before the intervention. On test day, they will follow a standardized low-FODMAP diet for three days and attend a laboratory visit for sample collection and testing. Breath samples will be collected at nine timepoints post-ingestion, and urine samples will be analyzed for metabolomics. The study measures include diagnostic breath profiles, hydrogen levels, intestinal gas monitoring, and clinical symptoms. A follow-up visit will confirm the capsules excretion and conclude participation.

CONDITIONS

Brief Title

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

Who Can Participate

Age: 18Years - 65Years

All Genders

Healthy Volunteers

Eligibility Criteria

You may qualify if you...

Men and women
Living in the Zurich area or nearby in Switzerland
Able and willing to provide informed consent and participate in study procedures
Aged 18 to 65 years at screening
Agree to avoid all other dairy intolerance treatments during the study
Willing to attend all study visits and complete procedures, including fasting
Able to understand and provide consent in English and/or German

You will not qualify if you...

Allergy to milk
Currently pregnant or lactating
Use of tobacco or nicotine products within 3 months before screening
Diagnosed with disorders affecting gastrointestinal motility such as gastroparesis, amyloidosis, neuromuscular diseases, collagen vascular diseases, alcoholism, uremia, malnutrition, or untreated hypothyroidism
History of gastrointestinal surgeries altering normal function (except uncomplicated surgeries over 12 months ago)
Suspected obscure gastrointestinal bleeding
Past or present organ transplant, chronic pancreatitis, pancreatic insufficiency, biliary disease, celiac disease, diverticular disease, inflammatory bowel disease, strictures, fistulas, gastrointestinal obstructions, or conditions confounding adverse event collection
Diabetes mellitus
Congestive heart failure
HIV, hepatitis B or C infection
Body mass index over 35 kg/m2
Swallowing disorders
Presence of implantable or portable electro-mechanical medical devices
Recent bowel preparation within 4 weeks
Chronic antacid or proton pump inhibitor use
Recent systemic antibiotic use within 2 months
History of alcohol or drug abuse in the past 12 months
Severe irritable bowel syndrome with symptom severity over 400
Vegan or vegetarian diet
Any conditions affecting participation or protocol compliance
Enrollment in another clinical trial within the last 3 months
Screening test showing GI symptoms with lactose ingestion and genetic lactase persistence

Research Team

Stamatios Giannoukos, PhD

Kathryn J. Pimentel, PhD

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