NCT06097182

Post-biotic Intervention for Acute Stress Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: Institute for Human Development and Potential (IHDP), Singapore · Academic / Other
• Sex: Male
• Age: 21 Years – 30 Years
• Healthy volunteers: Accepted

Summary

The study aims to evaluate the sub-chronic effects of colonic delivery of a post-biotic 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 post-biotic, when released in the colonic intestinal site, leads to a blunted subjective and objective stress response after a stress induction.

Detailed 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 post-biotic 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).

Conditions

• Stress Response
• Mood State
• Sleep
• Cognition

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Post-biotic (Colonic-Delivery capsule)	250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)
DIETARY_SUPPLEMENT	Post-biotic (Regular Administration capsule)	250mg post-biotic once daily in a regular uncoated vegan gelatine capsule
OTHER	Placebo	250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Timeline

• Start date: 2023-11-01
• Primary completion: 2024-06-14
• Completion: 2024-06-14
• First posted: 2023-10-24
• Last updated: 2024-08-16

Locations

1 site across 1 country: Singapore