BridgeMD
New treatment option for Lactose Intolerance
Official title Lactobreath: A Study to Diagnose Lactose Intolerance Using Breath Markers
ClinicalTrials.gov ID: NCT06177938
What this study is testing
- What it's testing
- Food intolerances affect many people and can cause discomfort and dietary challenges. One common cause is difficulty digesting certain carbohydrates called FODMAPs.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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...
- History of surgery that alters normal GI tract function, including but not limited to: GI bypass surgery, bariatric surgery, gastric banding...
See the full eligibility 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.
- 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...
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Zurich, Canton of Zurich, Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Zurich, Canton of Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.