Smart Underwear for Gastrointestinal Microbiome

Overseen By Noel T Mueller, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must not be taking: Chronic medications

Disqualifiers: Diabetes, Hypertension, Obesity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test Smart Underwear, which detects changes in gut gas production, specifically hydrogen sulfide, when people consume different diets. Participants will try two diets: one high in cysteine, a common amino acid, and one low in cysteine, to observe their effects on the gut. It suits generally healthy individuals with regular bowel movements who are open to discussing their digestive health. The trial requires participants to eat specific foods and adhere to the study’s meal plan. As an unphased trial, this study offers a unique opportunity to contribute to innovative research on digestive health technology.

Will I have to stop taking my current medications?

The trial does not specify if you must stop taking your current medications, but it excludes those on chronic medications for certain health conditions. It's best to discuss your specific medications with the trial coordinators.

What prior data suggests that this Smart Underwear device is safe?

Studies have shown that Smart Underwear is promising in terms of safety. In one study, the device accurately detected changes in gut gas levels, indicating effective performance without causing problems. Another study examined potential negative side effects, and the results showed that it is generally well-tolerated by users.

Additionally, other studies have used Smart Underwear to measure various types of gut activity without significant negative effects reported. This suggests it is safe for people to wear while collecting data. Although specific adverse events were not detailed, the absence of major problems in these studies suggests a favorable safety profile for this wearable device. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Smart Underwear trial because it explores a unique approach to understanding the gastrointestinal microbiome. Unlike traditional treatments that might involve medications or dietary supplements, this trial uses wearable technology to gather data. The Smart Underwear could provide continuous, non-invasive monitoring of the microbiome, offering insights that are more precise and personalized. By comparing the effects of a low cysteine diet and a high cysteine diet, researchers aim to uncover how dietary changes impact gut health, potentially leading to more tailored dietary recommendations in the future.

What evidence suggests that this Smart Underwear is effective for quantifying diet-induced changes in gut microbial hydrogen sulfide production?

Research has shown that Smart Underwear effectively detects changes in gut bacteria activity, with a 94.7% success rate in identifying increased activity four days after consuming certain foods. This trial will compare the effects of a Low Cysteine Diet and a High Cysteine Diet on gut bacteria activity. Smart Underwear will measure changes in hydrogen sulfide (H₂S), a gas produced by gut bacteria that can vary with diet. By accurately tracking these changes, the device aids in understanding how different foods affect gut health. Its ability to monitor these shifts suggests it could be a valuable tool for assessing dietary impacts on gut bacteria. ^{1 2 3 4 6}

Who Is on the Research Team?

Andrew B Hall, PhD

Principal Investigator

University of Maryland, College Park

Noel T Mueller, PhD

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

This trial is for individuals interested in helping test a Smart Underwear device that measures changes in gut hydrogen sulfide production due to diet. Participants will follow two different diets, one high and one low in cysteine, to see how it affects their gastrointestinal microbiome.

Inclusion Criteria

Willing to complete the entire study protocol, i.e. eating all of the food that is provided and completing all required measurements.

Willing to discuss flatus

I am generally healthy with no major illnesses.

Exclusion Criteria

Food preferences, intolerance, or dietary requirements that would interfere with diet adherence

Planned dietary changes during the study period

Lack of appropriate food refrigeration and preparation equipment (e.g.- oven or microwave)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Dietary Intervention Period 1

Participants follow a high cysteine or low cysteine diet while wearing the Smart Underwear device to measure H₂S production

6 days

Daily monitoring

Washout Period

Participants undergo an approximately 11-day washout period between dietary interventions

11 days

Dietary Intervention Period 2

Participants switch to the alternate diet (high cysteine or low cysteine) while continuing to wear the Smart Underwear device

6 days

Daily monitoring

Follow-up

Participants are monitored for safety and effectiveness after the dietary interventions

2-4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Smart Underwear

Trial Overview The study tests the effectiveness of Smart Underwear in detecting diet-induced shifts in gut microbial hydrogen sulfide levels. It involves a crossover design where participants alternate between high and low cysteine diets over separate periods with a break in between.

How Is the Trial Designed?

Group I: Low Cysteine Diet Experimental Treatment 1 Intervention

A dietary pattern designed to have a low level of dietary cysteine

Group II: High Cysteine Diet Active Control 1 Intervention

A dietary pattern designed to have a high level of dietary cysteine

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

University of Maryland, College Park

Collaborator

Trials

163

Recruited

46,800+

Published Research Related to This Trial

A new ingestible smart biosensing pill has been developed that can autonomously measure pH levels in the gastrointestinal tract, providing a non-invasive alternative to traditional diagnostic methods like colonoscopy.

The pill is equipped with advanced pH sensors and electronics, allowing for easy data collection after the pill is excreted, which could lead to more efficient and cost-effective monitoring of gastrointestinal diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ingestible pH sensing device for gastrointestinal health monitoring based on thread-based electrochemical sensors. Asci, C., Sharma, A., Del-Rio-Ruiz, R., et al.[2023]

Citations

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

Smart Underwear: A Novel Wearable for Long-Term ... 3. GUMDROP Study Results. The Smart Underwear detected a higher microbiome activity on day 4 after inulin gumdrop consumption in 36/38 (94.7%) ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06802276?term=AREA%5BInterventionSearch%5D(CYSTEINE%20HYDROCHLORIDE)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL)&rank=9

Smart Underwear to Measure Diet-Induced Hydrogen ... The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut microbial ...

3. withpower.com withpower.com/trial/smart-underwear-for-gastrointestinal-microbiome-a3d75

Smart Underwear for Gastrointestinal Microbiome The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut microbial ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT06724705

Testing the Capability of the Smart Underwear Device to ... Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption. ClinicalTrials.gov ID NCT06724705.

5. ctv.veeva.com ctv.veeva.com/study/smart-underwear-to-measure-diet-induced-hydrogen-sulfide-production

Smart Underwear to Measure Diet-Induced Hydrogen Sulfide ... The purpose of this study is to evaluate the ability of a wearable Smart Underwear prototype device to quantify diet-induced changes in gut ...

6. reporter.nih.gov reporter.nih.gov/search/10EECF0E478EC6D37598B8961CAA4A01A2FFCEB861BF/project-details/11136680

Employing smart underwear to measure gut microbial ... We have demonstrated that the Smart Underwear v1 prototype can precisely measure physiologically-relevant concentrations of H2S in vitro. When worn by humans, ...