Breath test could replace guesswork in lactose intolerance diagnosis

NCT ID NCT06177938

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
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Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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First seen Sep 15, 2026 · Last updated Sep 16, 2026 · Updated 1 time

Summary

Researchers at ETH Zurich are testing whether analyzing exhaled breath can diagnose lactose intolerance. The study includes 112 adults aged 18 to 65 in the Zurich area who consume a lactose or glucose solution. By measuring specific gases in the breath and comparing them to urine and genetic markers, the team aims to identify a breath profile that distinguishes people who digest lactose from those who do not.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lactose and glucose solutions
What this could lead to
If breath markers prove reliable, doctors could use a simple breath test to diagnose lactose intolerance and guide low-FODMAP diets.
What could go wrong
This is a small pilot study, so the breath markers may not be accurate enough for routine use, and results might not apply to other food intolerances.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

112 people

The number who actually took part.

Started

Jun 2024

Finished

Apr 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Food Intolerance lactose intolerance

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • ETH Zurich

    Zurich, Canton of Zurich, 8093, Switzerland

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