Postbiotic Intervention for Acute Stress Management — PIAS  

Sleep Clinical Trial

Official title: Postbiotic Intervention for Acute Stress Management

Status Recruiting

Clinical Trial Summary

The study aims to evaluate the sub-chronic effects of colonic delivery of a postbiotic on stress response, mood state, sleep, and cognition in healthy young subjects with elevated self-reported stress levels. It is hypothesized that oral intake of the postbiotic, when released in the colonic intestinal site, leads to a blunted subjective and objective stress response after a stress induction.

Clinical Trial Description

Scientific findings over the past years suggest that certain bacteria in our gastrointestinal system have an influence on our mood, although, the mechanisms are not yet well understood. One of the possibilities is that bacteria produce compounds that interact with neurons in the gut. These neurons could subsequently send signals to the brain.

This study is a proof of principle study examining the effects of a postbiotic in the distal intestinal tract (terminal ileum, colon) on stress response, mood state, sleep, and cognition. The study is expected to provide key insights in the potential of treatment strategies aimed at stimulating the colonic enteric nervous system to exert mood enhancement. It is hypothesized that interactions with the local Enteric Nervous System leading to stress reduction, mood enhancement and sleep promotion effects. The study will employ an in-person clinic visit, in addition to traditional self-reported, behavioural, and physiological outcome measures; exploratory digital health outcomes will also be included to identify novel objective mood/stress measures.

This study seeks to recruit a total of 75 healthy males (25 in each arm), between the ages of 21-30 years old (inclusive) from local community outreach in Singapore over a period 12 months. This study is a hybrid study (partially decentralized).

The total duration of participation from each participant will be 9 days (excluding, the screening and enrolment days). ;

Related Conditions & MeSH terms

• Cognition
• Sleep
• Stress Response

• NCT number: NCT06097182
• Study type: Interventional
• Source: Singapore Institute for Clinical Sciences
• Contact: Jeroen Schmitt, PhD
• Phone: 6407 4060
• Email: jeroen_schmitt@sics.a-star.edu.sg
• Status: Recruiting
• Phase: N/A
• Start date: October 2023
• Completion date: September 2024