Testing a smart underwear device for detecting lactose intolerance
Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
NA · University of Maryland, College Park · NCT06724705
This study is testing a smart underwear device to see if it can accurately detect lactose intolerance in adults by comparing its readings with their reported symptoms after eating lactose and sugar.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Maryland, College Park (other) |
| Locations | 1 site (College Park, Maryland) |
| Trial ID | NCT06724705 on ClinicalTrials.gov |
What this trial studies
This interventional study aims to validate the Smart Underwear device's ability to detect lactose intolerance by comparing its results with self-reported symptoms in adult participants. Participants will be divided into lactose-tolerant and lactose-intolerant groups and will consume both lactose and sucrose to assess the device's effectiveness in measuring flatus events and microbiome activity. The study involves a low-fiber/low-FODMAP diet, food logging, and wearing the device for 8 hours daily over three days. The goal is to determine if the device can reliably differentiate responses to lactose versus sucrose consumption.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and above who are either self-reported lactose intolerant or lactose tolerant without gastrointestinal disorders.
Not a fit: Patients with gastrointestinal disorders or those who experience adverse reactions to lactose or sucrose may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for diagnosing lactose intolerance.
How similar studies have performed: While the approach of using wearable technology for gastrointestinal monitoring is emerging, this specific application of the Smart Underwear device is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
College Park, Maryland
- Bioscience Research Building — College Park, Maryland, United States (RECRUITING)
Study contacts
- Study coordinator: Brantley Hall, PhD
- Email: brantley@umd.edu
- Phone: 5407978040
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lactose Intolerance, Adult Type