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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:
The randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Participants consume sucrose and wear the Smart Underwear device |
|
| Experimental | Experimental | Participants consume lactose and wear the Smart Underwear device |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactose | Dietary Supplement | Participants receive lactose to determine whether it changes gut microbial hydrogen production |
|
| Measure | Description | Time Frame |
|---|---|---|
| Microbiome activity index | 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. | 8 hours from consumption of the lactose and sucrose |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bioscience Research Building | College Park | Maryland | 20742 | United States |
The following Individual Participant Data (IPD) will be shared: Microbiome Activity Index measurements from both the sham control and lactose challenge arms, collected via the Smart Underwear device's electrochemical sensor array during the controlled crossover trial. The Microbiome Activity Index reflects the quantified hydrogen gas events exceeding baseline threshold during the monitoring period. The study protocol and informed consent documents will also be made available. The data represents measurements taken over 8-hour periods following oral lactose or sham administration while participants wore the device.
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| ID | Term |
|---|---|
| C562601 | Lactose Intolerance, Adult Type |
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| ID | Term |
|---|---|
| D007785 | Lactose |
| D013395 | Sucrose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Sucrose | Dietary Supplement | Participants will consume sucrose which they will consume as a placebo |
|
| Wear smart underwear | Device | Participants will wear the smart underwear device to measure the microbiome activity index |
|
| D000073893 |
| Sugars |