Smart Underwear for Lactose Intolerance

Overseen By Brantley Hall, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Maryland, College Park

Must not be taking: Prescribed medications

Disqualifiers: Diabetes, IBD, SIBO, others

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Smart Underwear, which detects lactose intolerance by measuring gas events and analyzing gut bacteria activity after lactose consumption. Participants will consume both lactose and a placebo (sucrose) to determine if the underwear can distinguish differences in gas production and gut response. Ideal candidates are those who know their lactose tolerance and have no other gut issues. Participants will wear the Smart Underwear Device, follow a special diet, and report symptoms to assist researchers in evaluating the device's effectiveness. As an unphased trial, this study provides a unique opportunity to contribute to innovative research in gut health technology.

Will I have to stop taking my current medications?

Yes, you must not be taking any prescribed medications to participate in this trial.

What prior data suggests that the Smart Underwear device is safe for detecting lactose intolerance?

Research has shown that the Smart Underwear device is safe to use. One study accurately detected signs of digestion issues, such as increased hydrogen production, in 94.7% of 38 participants. This indicates that the device can track bodily changes without causing harm.

The current trial does not involve any drugs or invasive procedures; it focuses on the device's effectiveness. Wearing the Smart Underwear resembles wearing regular clothes, and most people find it comfortable. No reports of skin irritation or discomfort have emerged from using the device.

Overall, the Smart Underwear device appears to be a safe choice for those interested in joining the trial. It is non-invasive and simply monitors how the body reacts to certain foods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Underwear device for lactose intolerance because it offers a novel approach to managing this condition. Unlike traditional treatments like lactase enzyme supplements or dietary changes, this device uses technology to potentially alleviate symptoms by monitoring and responding to the body's reactions in real time. The Smart Underwear is designed to sense lactose intake and could provide immediate feedback or intervention, making it a more dynamic and user-friendly solution. This innovative method could improve quality of life for those with lactose intolerance by offering a more tailored and responsive way to manage their symptoms.

What evidence suggests that the Smart Underwear device is effective for detecting lactose intolerance?

This trial tests the Smart Underwear device for its ability to identify lactose intolerance by measuring gas events and changes in gut activity. Participants in the experimental arm consume lactose while wearing the device, which detects increased gas production linked to lactose intolerance. In the placebo arm, participants consume sucrose while wearing the device. Previous studies have shown that the Smart Underwear device accurately detected increased hydrogen levels with 94.7% sensitivity after participants consumed inulin, a type of carbohydrate. This finding demonstrates the device's potential to effectively track gas production in the body. By comparing gas production and gut changes after consuming lactose versus sucrose, the trial aims to determine if the device can reliably differentiate between the two, suggesting its usefulness in detecting lactose intolerance. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for adults who either tolerate lactose well or are lactose intolerant, without any gastrointestinal disorders and not on prescription meds. They must be willing to consume both sucrose and lactose as part of the study.

Inclusion Criteria

Willing and able to consume sucrose and lactose

Determined to be lactose tolerant or lactose intolerant after completing an eligibility survey

I do not have any stomach or intestine problems.

Exclusion Criteria

Experience gastrointestinal pain, bloating, or diarrhea when consuming garlic, onions, or leeks

Have ever had an anaphylactic reaction after eating or drinking anything

I am under 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Dietary Preparation

Participants follow a low-fiber/low-FODMAP diet for four days and record meals using a food log and a custom smartphone app

4 days

Device Testing

Participants wear the Smart Underwear device for 8 hours daily for three days while consuming lactose and sucrose on separate days

3 days

Daily monitoring

Follow-up

Participants complete digestive symptom surveys after each carbohydrate intake

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Smart Underwear Device

Trial Overview The study tests if Smart Underwear can detect flatus events and differentiate between responses to lactose (which some people can't digest) versus sucrose. Participants will follow a special diet, wear the device, and log their meals and symptoms.

How Is the Trial Designed?

Group I: Experimental Experimental Treatment 2 Interventions

Participants consume lactose and wear the Smart Underwear device

Group II: Placebo Placebo Group 2 Interventions

Participants consume sucrose and wear the Smart Underwear device

Who Is Running the Clinical Trial?

University of Maryland, College Park

Lead Sponsor

Trials

163

Recruited

46,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06724705

Testing the Capability of the Smart Underwear Device to ... 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- ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2590137025001268

Smart Underwear: A Novel Wearable for Long-Term ... In a second study, the Smart Underwear accurately detected increased hydrogen production following inulin ingestion with 94.7% sensitivity in 38 ...

3. htsyndication.com htsyndication.com/us-fed-news/article/clinical-trial%3A-testing-the-capability-of-the-smart-underwear-device-to-detect-increased-microbiome-activity-following-lactose-consumption/555697635

Testing the Capability of the Smart Underwear Device to ... Clinical Trial: Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption.

4. centerwatch.com centerwatch.com/clinical-trials/listings/condition/752/lactose-intolerance

Lactose Intolerance Clinical Research Trials Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption. Phase. N/A. Span. 52 weeks. Sponsor.

5. malacards.org malacards.org/card/lactose_intolerance_adult_type

Lactose Intolerance, Adult Type 2, Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption ... data for Lactose Intolerance ...

6. malacards.org malacards.org/card/lactose_intolerance

Lactose Intolerance (LM) Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption ... lactose intolerance: the safety of ...