Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
NCT ID: NCT06724705
Last Updated: 2025-03-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
100 participants
INTERVENTIONAL
2024-12-05
2025-12-01
Brief Summary
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The main questions it aims to answer are:
Can the Smart Underwear device reliably measure flatus events after lactose consumption? Does the Microbiome Activity Index differentiate between responses to lactose and sucrose consumption?
Researchers will compare participants consuming lactose (experimental arm) with their results after consuming sucrose (placebo arm) to see if the device detects increased flatus events and higher Microbiome Activity Index values in the lactose arm.
Participants will:
* Follow a low-fiber/low-FODMAP diet for four days.
* Record meals using a food log and a custom smartphone app.
* Wear the Smart Underwear device for 8 hours daily for three days.
* Fast for 12 hours overnight, consume 20 grams of either lactose or sucrose dissolved in water, and continue fasting for an additional 4 hours.
* Fast for 12 hours overnight, consume 20 grams of the carbohydrate they did not consume the first time (lactose or sucrose) dissolved in water, and continue fasting for an additional 4 hours.
* Complete digestive symptom surveys after each carbohydrate intake.
The randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Placebo
Participants consume sucrose and wear the Smart Underwear device
Sucrose
Participants will consume sucrose which they will consume as a placebo
Wear smart underwear
Participants will wear the smart underwear device to measure the microbiome activity index
Experimental
Participants consume lactose and wear the Smart Underwear device
Lactose
Participants receive lactose to determine whether it changes gut microbial hydrogen production
Wear smart underwear
Participants will wear the smart underwear device to measure the microbiome activity index
Interventions
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Lactose
Participants receive lactose to determine whether it changes gut microbial hydrogen production
Sucrose
Participants will consume sucrose which they will consume as a placebo
Wear smart underwear
Participants will wear the smart underwear device to measure the microbiome activity index
Eligibility Criteria
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Inclusion Criteria
* Not consuming any prescribed medications
* Willing and able to consume sucrose and lactose
* Determined to be lactose tolerant or lactose intolerant after completing an eligibility survey
Exclusion Criteria
* Diagnosed with or suspected to have the following conditions: diabetes, prediabetes, high blood sugar, IBD, SIBO, or a food allergy to sucrose or lactose
* Experience gastrointestinal pain, bloating, or diarrhea when consuming garlic, onions, or leeks
* Routinely experience constipation or painful constipation
* Have ever had an anaphylactic reaction after eating or drinking anything
18 Years
ALL
Yes
Sponsors
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University of Maryland, College Park
OTHER
Responsible Party
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Locations
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Bioscience Research Building
College Park, Maryland, United States
Countries
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Central Contacts
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Other Identifiers
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Smart Underwear Lactose
Identifier Type: -
Identifier Source: org_study_id
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