4 results
Primary Safety Endpoint:Safety will be assessed by incidence and severity of adverse events through 12-weeks (3 month) follow-up. Included in this assessment will be the proportion of subjects with any of the following outcomes between device…
Primary Exploratory Objective:* To explore the effect of Lactobacillus casei strain Shirota (LcS) on small intestinal microbiota profiles.Secondary Exploratory Objectives:* To explore the differences between the effect of LcS on small intestinal and…
The primary objective of this study is to determine the point accuracy of a microdialysis*based continuous glucose monitoring system. Secondary objectives include trend accuracy and reliability of the system.
Primary Objective: Therapeutic effect of electrical stimulation. Secondary Objective(s): (i) Side effects of electrical stimulation(ii) Effect on quality of life (iii) Effect of electrical stimulation on inflammatory and histologic parameters.