Stress ResponsePIASNCT06097182
Post-biotic Intervention for Acute Stress Management
A study testing Post-biotic (Colonic-Delivery capsule) and Post-biotic (Regular Administration capsule) in people with Stress Response and Mood State, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stress Response, Mood State, Sleep
- What is being tested?
- Post-biotic (Colonic-Delivery capsule) and Post-biotic (Regular Administration capsule)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Nov 2023to 14 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- Willing and able to participate and to give written informed consent All inclusion criteria will be assessed based on self-reported information during the screening visit.
Who cannot join
- 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
- Members of the research team or their immediate family members. An immediate family member is defined as spouse, parent, child, or sibling, whether biological or legally adopted All exclusion criteria will be assessed based on self-reported information during the screening call.
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Human Development Research Centre, SICS, A*STAR
Singapore, 117597
About this study
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.
Read the 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
- Being tested
- Post-biotic (Colonic-Delivery capsule), Post-biotic (Regular Administration capsule), Placebo
- Keywords
- gut-brain-axis, stress response, Cognition, Mood State, Sleep
- Medical subject headings
- Fractures, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-biotic (Colonic-Delivery capsule)Dietary supplement
250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery)
Post-biotic (Regular Administration capsule)Dietary supplement
250mg post-biotic once daily in a regular uncoated vegan gelatine capsule
PlaceboOther
250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule
| Study group | Role | What they receive |
|---|---|---|
| Post-biotic, colonic delivery | Experimental | n=25, 250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery) Receives: Dietary Supplement: Post-biotic (Colonic-Delivery capsule); Other: Placebo |
| Post-biotic, regular administration | Active comparator | n=25, 250mg post-biotic once daily in a regular uncoated vegan gelatine capsule Receives: Dietary Supplement: Post-biotic (Regular Administration capsule); Other: Placebo |
| Placebo | Placebo comparator | n=25, 250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Salivary Cortisol
cortisol levels, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation
Measured: Day 7 (5/day)
Secondary outcomes (4)
State Trait Anxiety Inventory (STAI-6)
The STAI-6 is a validated short-form version (6 items) of the 40-item STAI questionnaire, measuring current anxiety symptoms on a 4-point Likert scale. Total score is calculated (range 6-24).
Measured: Day 7 (2/day)
The Brunel Mood Scale (BRUMS)
The BRUMS is a 24-item questionnaire of simple mood descriptors such as angry, nervous, unhappy, and energetic. The BRUMS has six subscales, with each of the subscales containing four mood descriptors. The subscales are anger, confusion, depression, fatigue, tension, and vigour. Responses are recorded using a 5-point Likert scale (0-4).
Measured: Day 7 (2/day)
Heart Rate
Measured as beats per minute. Continuous monitoring via a smart-watch.
Measured: Days 1-7
Sleep Activity
During sleep, the activity will be monitored via a smart-watch throughout the sleep session.
Measured: Days 1-7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2023
- Study start1 Nov 2023
- Primary completion14 Jun 2024
- Study completion14 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Stress ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute for Human Development and Potential (IHDP), Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeroen Schmitt, Institute for Human Development and Potential (IHDP), Singapore
- Investigators
- Jeroen Schmitt, PhD, Principal investigator, Singapore Institute of Clinical Sciences (SICS), A*STAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06097182
- Sponsor's protocol ID
- 2023-086
- Acronym
- PIAS
- Status last verified
- Aug 2024
- First submitted
- 13 Oct 2023
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Boets E, Gomand SV, Deroover L, Preston T, Vermeulen K, De Preter V, Hamer HM, Van den Mooter G, De Vuyst L, Courtin CM, Annaert P, Delcour JA, Verbeke KA. Systemic availability and metabolism of colonic-derived short-chain fatty acids in healthy subjects: a stable isotope study. J Physiol. 2017 Jan 15;595(2):541-555. doi: 10.1113/JP272613. Epub 2016 Sep 18.
PubMed 27510655
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-biotic Intervention for Acute Stress Management
- ClinicalTrials.gov ID
- NCT06097182
- Acronym / sponsor ID
- PIAS / 2023-086
- Conditions
- Stress Response, Mood State, Sleep, Cognition
- Keywords
- gut-brain-axis, stress response, Cognition, Mood State, Sleep
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Institute for Human Development and Potential (IHDP), SingaporeUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 14 Jun 2024 (actual)
- Study completion
- 14 Jun 2024 (actual)
- First posted
- 24 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Post-biotic, colonic delivery | Experimental | Dietary Supplement: Post-biotic (Colonic-Delivery capsule), Other: Placebon=25, 250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery) |
| Post-biotic, regular administration | Active comparator | Dietary Supplement: Post-biotic (Regular Administration capsule), Other: Placebon=25, 250mg post-biotic once daily in a regular uncoated vegan gelatine capsule |
| Placebo | Placebo comparator | Other: Placebon=25, 250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule |
Who may qualify
- Ages
- 21 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-biotic (Colonic-Delivery capsule)250mg post-biotic once daily in a polymer coated vegan gelatine capsule (colonic delivery) | Dietary supplement | Post-biotic, colonic delivery |
| Post-biotic (Regular Administration capsule)250mg post-biotic once daily in a regular uncoated vegan gelatine capsule | Dietary supplement | Post-biotic, regular administration |
| Placebo250mg Maltodextrin once daily in a regular uncoated vegan gelatine capsule | Other | Placebo, Post-biotic, colonic delivery, Post-biotic, regular administration |
Primary outcome
Salivary Cortisol
Time frame: Day 7 (5/day)
cortisol levels, as a marker of hypothalamic-pituitary-adrenal (HPA) axis activation
4 secondary outcomes
State Trait Anxiety Inventory (STAI-6)
Time frame: Day 7 (2/day)
The Brunel Mood Scale (BRUMS)
Time frame: Day 7 (2/day)
Heart Rate
Time frame: Days 1-7
Sleep Activity
Time frame: Days 1-7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2024.
- Background: PubMed 27510655Boets E, Gomand SV, Deroover L, Preston T, Vermeulen K, De Preter V, Hamer HM, Van den Mooter G, De Vuyst L, Courtin CM, Annaert P, Delcour JA, Verbeke KA. Systemic availability and metabolism of colonic-derived short-chain fatty acids in healthy subjects: a stable isotope study. J Physiol. 2017 Jan 15;595(2):541-555. doi: 10.1113/JP272613. Epub 2016 Sep 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeroen Schmitt, PhD principal investigator
Singapore Institute of Clinical Sciences (SICS), A*STAR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-biotic (Colonic-Delivery capsule) and Post-biotic (Regular Administration capsule) in people with Stress Response and Mood State, run by Institute for Human Development and Potential (IHDP), Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary Cortisol (time frame: Day 7 (5/day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06097182, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2024.