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

Trial Summary

What is the purpose of this trial?

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 hydrogen sulfide (H₂S) production. The core design is a single-site, 2-period, crossover feeding study with 6-day diet periods and an approximately 11-day washout period. Participants are fed each of two isocaloric diets designed to contrast gut microbial H₂S production (i.e., a high cysteine vs. low cysteine diet), in a random order.

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 data supports the effectiveness of the treatment Smart Underwear for gastrointestinal microbiome?

The research on a smart capsule for targeted microbiome sampling shows that non-invasive methods can effectively collect gut microbiome data, which is crucial for understanding and potentially treating gastrointestinal issues. This suggests that similar non-invasive technologies, like Smart Underwear, could be effective in monitoring and managing gut health. ^{1 2 3 4 5}

Is Smart Underwear for gastrointestinal microbiome sampling safe for humans?

The research on similar devices, like ingestible capsules for gut microbiome sampling, shows no signs of local tissue inflammation or toxicity in animal models, suggesting they are generally safe. ^{2 6 7 8 9}

How does the Smart Underwear treatment differ from other treatments for gastrointestinal microbiome issues?

The Smart Underwear treatment is unique because it likely involves a non-invasive method to monitor or interact with the gastrointestinal microbiome, potentially using wearable technology, unlike traditional invasive procedures like colonoscopies or endoscopies. This approach could provide continuous, real-time data on the gut microbiome, offering a novel way to understand and manage gastrointestinal health. ^{2 10 11 12 13}

Research Team

Noel T Mueller, PhD

Principal Investigator

University of Colorado, Denver

Andrew B Hall, PhD

Principal Investigator

University of Maryland, College Park

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Artificial intelligence-based personalized diet: A pilot clinical study for irritable bowel syndrome. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Smart capsule for targeted proximal colon microbiome sampling. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Methane and fatty acid metabolism pathways are predictive of Low-FODMAP diet efficacy for patients with irritable bowel syndrome. [2021]

4. England pubmed.ncbi.nlm.nih.gov

A hands-free stool sampling system for monitoring intestinal health and disease. [2023]

5. England pubmed.ncbi.nlm.nih.gov

On the robustness of inference of association with the gut microbiota in stool, rectal swab and mucosal tissue samples. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

An in vitro platform for study of the human gut microbiome under an oxygen gradient. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

The Use of a Mini-Bioreactor Fermentation System as a Reproducible, High-Throughput ex vivo Batch Model of the Distal Colon. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Electrochemical (Bio)Sensing Devices for Human-Microbiome-Related Biomarkers. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

An Ingestible Self-Polymerizing System for Targeted Sampling of Gut Microbiota and Biomarkers. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Smart capsule for non-invasive sampling and studying of the gastrointestinal microbiome. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Recognition Engineering-Mediated Multichannel Sensor Array for Gut Microbiota Sensing. [2023]

12. Austria pubmed.ncbi.nlm.nih.gov

Ingestible pH sensing device for gastrointestinal health monitoring based on thread-based electrochemical sensors. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

An ingestible bacterial-electronic system to monitor gastrointestinal health. [2020]