Document Type
Oral Presentation
Location
Oxford Conference Center, Oxford MS
Event Website
https://oxfordicsb.org/
Start Date
8-4-2025 1:30 PM
Description
Direct-to-consumer decentralized clinical trials (DCTs) conducted with mobile digital technologies and at-home or local clinical testing are accelerating rigorous clinical studies by virtualizing study activities and collecting data from mobile devices and web-based systems. Through technology automations, decentralized study designs allow for high quality and compliance with objective and subjective data collection. The result is increased study efficiency, high rigor, and more diverse participation, while generating high quality data to meet regulatory standards. Using a proprietary clinical trial software application Chloe, we conducted a double-blinded, randomized, placebo-controlled trial with optional open label extension investigating the impact of 2 doses of an oral probiotic containing the strain Lactiplantibacillus plantarum on anxiety, sleep, mood, quality of life, cognition, heart rate variability and adverse events in adults (n=83, age 39 ± 13 years, 63% female, 64% Caucasian) with mild to moderate anxiety over a 6-week period. Participants receiving treatment doses exhibited significantly lower GAD-7 scores at weeks 4 and 6. [ADDITIONAL DATA TO BE SHARED]. No serious adverse events occurred. A daily probiotic containing L. plantarum significantly reduced anxiety in adults with mild to moderate anxiety at 4 and 6 weeks following daily consumption. GABA-producing probiotics may offer a safe option for anxiety reduction. The successful scientific conduct of this study demonstrates the potential to elevate industry standards and accelerate clinical trials growth. The DCT model offers cost-effective and efficient clinical trials, promising advancements in consumer health research.
Recommended Citation
Tan, Belinda, "Innovation Meets Rigor: A Case Study of Decentralized Clinical Trials in Consumer Health Research" (2025). Oxford ICSB. 25.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/25
Publication Date
April 2025
Accessibility Status
Screen reader accessible, Searchable text
Included in
Innovation Meets Rigor: A Case Study of Decentralized Clinical Trials in Consumer Health Research
Oxford Conference Center, Oxford MS
Direct-to-consumer decentralized clinical trials (DCTs) conducted with mobile digital technologies and at-home or local clinical testing are accelerating rigorous clinical studies by virtualizing study activities and collecting data from mobile devices and web-based systems. Through technology automations, decentralized study designs allow for high quality and compliance with objective and subjective data collection. The result is increased study efficiency, high rigor, and more diverse participation, while generating high quality data to meet regulatory standards. Using a proprietary clinical trial software application Chloe, we conducted a double-blinded, randomized, placebo-controlled trial with optional open label extension investigating the impact of 2 doses of an oral probiotic containing the strain Lactiplantibacillus plantarum on anxiety, sleep, mood, quality of life, cognition, heart rate variability and adverse events in adults (n=83, age 39 ± 13 years, 63% female, 64% Caucasian) with mild to moderate anxiety over a 6-week period. Participants receiving treatment doses exhibited significantly lower GAD-7 scores at weeks 4 and 6. [ADDITIONAL DATA TO BE SHARED]. No serious adverse events occurred. A daily probiotic containing L. plantarum significantly reduced anxiety in adults with mild to moderate anxiety at 4 and 6 weeks following daily consumption. GABA-producing probiotics may offer a safe option for anxiety reduction. The successful scientific conduct of this study demonstrates the potential to elevate industry standards and accelerate clinical trials growth. The DCT model offers cost-effective and efficient clinical trials, promising advancements in consumer health research.
https://egrove.olemiss.edu/icsb/2025_ICSB/Schedule/25