Lactose Intolerance, Adult TypeNCT06724705
Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
A study testing Lactose, Sucrose and Wear smart underwear in people with Lactose Intolerance, Adult Type, run by University of Maryland, College Park at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lactose Intolerance, Adult Type
- What is being tested?
- Lactose, Sucrose and Wear smart underwear
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Bioscience Research Building
College Park, Maryland, 20742
About this study
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:
Read more
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:
- Follow a low-fiber/low-FODMAP diet for four days.
- Record meals using a food log and a custom smartphone app.
- Wear the Smart Underwear device for 8 hours daily for three days.
- Fast for 12 hours overnight, consume 20 grams of either lactose or sucrose dissolved in water, and continue fasting for an additional 4 hours.
- Fast for 12 hours overnight, consume 20 grams of the carbohydrate they did not consume the first time (lactose or sucrose) dissolved in water, and continue fasting for an additional 4 hours.
- Complete digestive symptom surveys after each carbohydrate intake.
The randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.
- Conditions
- Lactose Intolerance, Adult Type
- Being tested
- Lactose, Sucrose, Wear smart underwear
- Medical subject headings
- Lactose Intolerance, Adult Type
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LactoseDietary supplement
Participants receive lactose to determine whether it changes gut microbial hydrogen production
SucroseDietary supplement
Participants will consume sucrose which they will consume as a placebo
Wear smart underwearDevice
Participants will wear the smart underwear device to measure the microbiome activity index
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Participants consume sucrose and wear the Smart Underwear device Receives: Dietary Supplement: Sucrose; Device: Wear smart underwear |
| Experimental | Experimental | Participants consume lactose and wear the Smart Underwear device Receives: Dietary Supplement: Lactose; Device: Wear smart underwear |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 hours from consumption of the lactose and sucrose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start5 Dec 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lactose Intolerance, Adult TypeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06724705
- Sponsor's protocol ID
- Smart Underwear Lactose
- Status last verified
- Apr 2026
- First submitted
- 25 Nov 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
- ClinicalTrials.gov ID
- NCT06724705
- Acronym / sponsor ID
- Smart Underwear Lactose
- Conditions
- Lactose Intolerance, Adult Type
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Study start
- 5 Dec 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 9 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Follow a low-fiber/low-FODMAP diet for four days.
- Record meals using a food log and a custom smartphone app.
- Wear the Smart Underwear device for 8 hours daily for three days.
- Fast for 12 hours overnight, consume 20 grams of either lactose or sucrose dissolved in water, and continue fasting for an additional 4 hours.
- Fast for 12 hours overnight, consume 20 grams of the carbohydrate they did not consume the first time (lactose or sucrose) dissolved in water, and continue fasting for an additional 4 hours.
- Complete digestive symptom surveys after each carbohydrate intake.
The randomized crossover design ensures that participants consume both lactose and sucrose on separate days, with blinding maintained for both participants and researchers.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Sucrose, Device: Wear smart underwearParticipants consume sucrose and wear the Smart Underwear device |
| Experimental | Experimental | Dietary Supplement: Lactose, Device: Wear smart underwearParticipants consume lactose and wear the Smart Underwear device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LactoseParticipants receive lactose to determine whether it changes gut microbial hydrogen production | Dietary supplement | Experimental |
| SucroseParticipants will consume sucrose which they will consume as a placebo | Dietary supplement | Placebo |
| Wear smart underwearParticipants will wear the smart underwear device to measure the microbiome activity index | Device | Experimental, Placebo |
Primary outcome
Microbiome activity index
Time frame: 8 hours from consumption of the lactose and sucrose
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Individual participant dataSharing planned: Yes. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactose, Sucrose and Wear smart underwear in people with Lactose Intolerance, Adult Type, run by University of Maryland, College Park at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiome activity index (time frame: 8 hours from consumption of the lactose and sucrose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.