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NCT06724705 · ClinicalTrials.gov registry record · NA
Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption
A NA study of Lactose Intolerance, Adult Type, sponsored by University of Maryland, College Park.
- Recruiting
- Registry status
- NA
- Development phase
- 100
- Enrollment target
- 1
- Study location
NCT06724705: Recruiting NA study of Lactose Intolerance, Adult Type, sponsored by University of Maryland, College Park.
NCT06724705 is a NA study of Lactose Intolerance, Adult Type that is actively recruiting participants, run by University of Maryland, College Park. The registered enrollment target is 100 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06724705, a NA study of Lactose Intolerance, Adult Type, is actively recruiting participants, sponsored by University of Maryland, College Park.
- RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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 activi
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Lactose
- DIETARY_SUPPLEMENT Sucrose
- DEVICE Wear smart underwear
Study Locations (1)
Maryland
- Bioscience Research Building - College Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2024-12-05 |
| Est. Completion | 2025-12-01 |
| Phase | NA |
What NCT06724705 shows while recruiting
NCT06724705 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Lactose Intolerance, Adult Type appearing as the primary indexed condition, and to 3 interventions - of which Lactose is the first listed.
NCT06724705 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT06724705 about?
NCT06724705 is a clinical study titled "Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption". 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 individual...
What is the current status of trial NCT06724705?
This trial is currently recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2024-12-05. Estimated completion is 2025-12-01.
What conditions does trial NCT06724705 study?
This clinical trial studies the following conditions: Lactose Intolerance, Adult Type.
What interventions are being tested in trial NCT06724705?
The interventions under investigation include: Lactose (DIETARY_SUPPLEMENT), Sucrose (DIETARY_SUPPLEMENT), Wear smart underwear (DEVICE).
Who is sponsoring clinical trial NCT06724705?
This trial is sponsored by University of Maryland, College Park, which has 46 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06724705 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06724705's enrollment target sits among peer trials
100 840th of 2000 higher than 1,081 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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