Protocol Section
The Protocol Section is one of the main sections in ClinicalTrials.gov data structure. It contains protocol-related information for clinical trials, including identification, status, design, eligibility, and other key details about how the trial is structured and conducted.
Protocol Section path is as follows:
Study -> Protocol Section -> Protocol Modules (Identification, Status, Design, Eligibility, etc.)
Protocol Section
Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2025-12-25 @ 3:27 AM
NCT ID:
NCT06724705
Description:
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:
NCT06724705
Study Brief:
Testing the Capability of the Smart Underwear Device to Detect Increased Microbiome Activity Following Lactose Consumption