Post-biotic Intervention for Acute Stress Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-06-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Probiotics on Sleep Among Adults Study

NCT04767997

Sleep Disturbance Sleep Patterns

COMPLETED PHASE2

Investigating a Probiotic on Mothers' Mood and Stress

NCT04685252

Perinatal Problems Mood Change Stress-related Problem

COMPLETED NA

The Efficacy of a Probiotic Blend on Stress in Moderately Stressed Teens

NCT05766306

Stress

COMPLETED PHASE2

Study on the Effects of a Probiotic on Autonomic and Psychological Stress

NCT02417454

Stress, Psychological

COMPLETED PHASE3

Pilot Study to Assess the Effect of a Probiotic Blend on Moderate Self-reported Anxiety.

NCT05562752

Anxiety

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Stress Response Mood State Sleep Cognition

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Study design: The study will be carried out according to a randomized, placebo-controlled, double-blind, 3 arm parallel-groups design. It will be executed as a hybrid study (partially decentralized). Total study duration is 9 days (day 0 to day 8), excluding screening and enrolment.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Post-biotic, colonic delivery

n=25, 250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)

Group Type EXPERIMENTAL

Post-biotic (Colonic-Delivery capsule)

Intervention Type DIETARY_SUPPLEMENT

250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)

Placebo

Intervention Type OTHER

250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Post-biotic, regular administration

n=25, 250mg post-biotic once daily in a regular uncoated vegan gelatine capsule

Group Type ACTIVE_COMPARATOR

Post-biotic (Regular Administration capsule)

Intervention Type DIETARY_SUPPLEMENT

250mg post-biotic once daily in a regular uncoated vegan gelatine capsule

Placebo

Intervention Type OTHER

250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Placebo

n=25, 250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Post-biotic (Colonic-Delivery capsule)

250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)

Intervention Type DIETARY_SUPPLEMENT

Post-biotic (Regular Administration capsule)

250mg post-biotic once daily in a regular uncoated vegan gelatine capsule

Intervention Type DIETARY_SUPPLEMENT

Placebo

250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Aged 21 to 30 years
* Men
* Perceived Stress Scale (PSS-10) score \>13
* Own and uses a smartphone that is capable to run the study applications with access to the internet
* Adequate fluency in the English language to understand the inform consent process, study instructions and study assessments
* Sufficient vision and hearing to complete study procedures
* Willing to commit to the study procedures

Exclusion Criteria

* Past (\< 6 months prior to the study) or current major neurological, psychiatric, gastrointestinal, metabolic disease or cardiovascular disease
* Past (\<1 months prior to the study) or current use of psychoactive medication, cardiovascular medication, or corticosteroids.
* Known medical history of hypotension or currently on antihypertensive medication
* Alcohol intake \>1 units day
* Present or past history of alcohol or drug addiction and/or recreational drug use
* BMI \<18.5 or \>25 kg/m2
* Maltodextrin allergy

Minimum Eligible Age

21 Years

Maximum Eligible Age

30 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes