Clinical trial NCT06724705: Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
Official title: Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lactose Intolerance, Adult Type
Lead sponsor: University of Maryland, College Park
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this Interventional study is to validate the Smart Underwear device's ability to detect lactose intolerance by comparing its results to self-reported symptoms in adult participants aged 18 and above, divided equally between self-reported lactose-tolerant and lactose-intolerant individuals.

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.


Eligibility criteria: Inclusion Criteria:

* Has no gastrointestinal disorders
* 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:

* Younger than 18 years old
* 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

Primary outcomes:
measure: Microbiome activity index
timeFrame: 8 hours from consumption of the lactose and sucrose
Secondary outcomes:
Other outcomes:
Locations:
city: College Park
country: United States
facility: Bioscience Research Building
state: Maryland
Study officials:
References: