Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 37
- Locations
- 2
- Primary Endpoint
- Microbiome activity index
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
Placebo
Participants consume sucrose and wear the Smart Underwear device
Intervention: Sucrose (Dietary Supplement)
Placebo
Participants consume sucrose and wear the Smart Underwear device
Intervention: Wear smart underwear (Device)
Experimental
Participants consume lactose and wear the Smart Underwear device
Intervention: Lactose (Dietary Supplement)
Experimental
Participants consume lactose and wear the Smart Underwear device
Intervention: Wear smart underwear (Device)
Outcomes
Primary Outcomes
Microbiome activity index
Time Frame: 8 hours from consumption of the lactose and sucrose
The Microbiome Activity Index A high gut microbiome activity is closely correlated with hydrogen gas production, reflected in the increase of both flatus frequency and hydrogen concentration. It is essential to consider these two variables together. The accumulated gas can be expelled in a few high-intensity events or through a series of smaller flatus. Consequently, relying solely on counting flatus or measuring only the sensor output does not provide a complete picture of gut microbiome activity. Additionally, the investigators found that high concentrations of hydrogen in flatus can sometimes saturate the sensor. To address this issue, the investigators discovered that using the absolute value of the sensor signal's first derivative offers a more accurate assessment of flatus intensity. By measuring the rate of change rather than the signal output, the method can reduce the baseline contribution and better identify flatus.
Secondary Outcomes
No secondary outcomes reported