Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT06177938

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

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

120

Participants Needed

1

Research Sites

75 weeks

Total Duration

On this page

Sponsors

E

ETH Zurich

Lead Sponsor

A

Agroscope Liebefeld-Posieux Research Station ALP

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Men and women
  • Living in Zurich area or beyond in Switzerland
  • Able and willing to provide informed consent and participate in study procedures
  • Aged 18-65 years at screening
  • Agree to avoid treatments or products for dairy intolerance during the study
  • Willing to attend all study visits and complete all procedures, including fasting before and during intervention
  • Able to understand and provide written consent in English and/or German
Not Eligible

You will not qualify if you...

  • Allergy to milk
  • Currently pregnant or lactating
  • Smoking or use of tobacco/nicotine products within 3 months
  • Diagnosed with disorders affecting gastrointestinal motility (e.g., gastroparesis, Parkinson's disease, amyloidosis)
  • History of GI surgeries that alter function (e.g., bypass, bariatric surgery), except uncomplicated abdominal surgeries over 12 months ago
  • Suspected obscure gastrointestinal bleeding
  • Past or present organ transplant or chronic pancreatitis
  • Conditions like pancreatic insufficiency, biliary disease, celiac disease, diverticular disease, inflammatory bowel disease, strictures, fistulas, or GI obstruction
  • Diabetes mellitus or congestive heart failure
  • Infection with HIV, hepatitis B or C
  • Body mass index over 35 kg/m2
  • Swallowing disorders or dysphagia
  • Presence of implantable or portable electro-mechanical medical devices
  • Recent bowel preparation within 4 weeks
  • Chronic use of antacids or proton pump inhibitors
  • Use of systemic antibiotics within 2 months
  • History of alcohol or drug abuse in past 12 months
  • Severe irritable bowel syndrome (IBS) with symptom severity score over 400
  • Vegan or vegetarian diet
  • Any other conditions affecting participation or protocol compliance as noted by study staff
  • Enrollment in another clinical trial within last 3 months
  • Screening test showing GI symptoms with lactose ingestion and genetic lactase persistence

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ETH Zurich

Zurich, Canton of Zurich, Switzerland, 8093

Actively Recruiting

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Research Team

S

Stamatios Giannoukos, PhD

CONTACT

K

Kathryn J. Pimentel, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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