HealthyPhase 2NCT07511855
Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel
A Phase 2 study testing Probiotic in people with Healthy, run by Min-Tze LIONG at 1 site in Hong Kong.
Trial summary
This study aims to evaluate the effects of a dual Bifidobacterium longum probiotic formulation (dipro-O and dipro-X) on sleep quality, stress responses, and gut microbiota stability in healthy adults during short-term travel. Read more about this study
- Who is it for?
- Ages 25 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Jul 2026to 31 May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
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 25 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Willing to participate in this study and able to provide written informed consent before any study procedures are initiated.
- Able and willing to comply with all study procedures as required by the protocol, including continuous wearable device use, saliva and stool sample collection, and completion of questionnaire assessments.
- Willing to accept randomization and group allocation as determined by the study protocol.
Who cannot join
- Known use of antibiotics or systemic corticosteroids within 4 weeks prior to enrollment.
- Use of probiotic supplements within 4 weeks prior to enrollment.
- Planned use of any probiotic supplements during the study period.
- Known history or current presence of major endocrine disorders, active inflammatory bowel disease or other severe gastrointestinal diseases, or severe sleep disorders requiring treatment adjustment.
- Pregnant or intend to get pregnant, or lactating women.
- Known allergy to any probiotic products.
- Participation in any other clinical interventional study involving drugs, dietary supplements, probiotics, or prebiotics within the past three months.
- Or those who, according to the researcher's judgment, may have inadequate adherence or are unable to complete the study protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Jie Yuan, M.Sc. contact
Hong Kong1 site
The Hong Kong Polytechnic University
Kowloon, Kowloon
Daisy Zhao, Ph.D., 3400 8680, daisydy.zhao@polyu.edu.hk
Jie Yuan, M.Sc., peanut.yuan@diprobio.com
About this study
Official title: Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel: A Randomized, Double-blind, Placebo-controlled Study
This study aims to evaluate the effects of a dual Bifidobacterium longum probiotic formulation (dipro-O and dipro-X) on sleep quality, stress responses, and gut microbiota stability in healthy adults during short-term travel. Using a randomized, double-blind, placebo-controlled design, the study investigates whether probiotic supplementation can enhance sleep resilience, buffer stress, and modulate microbiome and physiological responses under travel-related environmental changes.
Read the detailed description
With increasing global mobility, short-term travel has become a common aspect of modern life. However, rapid environmental transitions, including changes in time zones, diet, daily routines, and psychosocial stress, can disrupt physiological homeostasis. Among the most affected systems are sleep regulation, stress responses, and gut microbiota composition. Travel-related circadian misalignment and psychological stress are known to impair sleep quality, while dietary shifts and environmental exposure can alter gut microbial balance, potentially leading to gastrointestinal discomfort, immune dysregulation, and reduced overall well-being.
Emerging evidence highlights the central role of the gut-brain axis in mediating interactions between microbiota, stress, and sleep. Alterations in gut microbiota can influence neuroendocrine pathways, including the hypothalamic-pituitary-adrenal (HPA) axis, as well as neurotransmitter systems involved in sleep and mood regulation. Consequently, maintaining microbiota stability during periods of acute stress, such as travel, may be critical for preserving both physiological and psychological resilience.
Probiotics have gained increasing attention as a potential strategy to support health under such conditions. Defined as live microorganisms that confer health benefits when administered in adequate amounts, probiotics, particularly strains within the Bifidobacterium genus, have been shown to modulate gut microbiota composition, enhance barrier function, regulate immune responses, and influence neuroendocrine signaling. Certain Bifidobacterium longum strains have demonstrated beneficial effects on stress reduction, sleep quality, and emotional regulation, suggesting their potential role in mitigating travel-related disturbances.
In this study, a dual-strain formulation containing Bifidobacterium longum subsp. longum dipro-O and dipro-X is employed, selected for their potential synergistic effects on microbiota modulation and stress resilience. These strains are hypothesized to support gut microbial stability, regulate stress-related biomarkers such as cortisol and salivary α-amylase, and improve sleep-related outcomes through modulation of neuroendocrine and microbial pathways.
To comprehensively evaluate these effects, the study integrates clinical, physiological, and multi-omics approaches. Sleep quality is assessed using both subjective (PSQI) and objective (wearable-derived) measures, while psychological status is evaluated using validated questionnaires (DASS-42, WHO-5). Biological samples, including saliva and feces, are collected to assess stress biomarkers, immune and inflammatory markers, and gut microbiota composition and function using metagenomic sequencing.
Importantly, the study adopts a longitudinal design encompassing pre-travel, travel, and post-travel phases, allowing for the assessment of dynamic changes and recovery patterns. This approach enables evaluation of not only the immediate effects of probiotic supplementation but also its potential to enhance resilience and facilitate recovery following environmental stress.
Overall, this study aims to provide mechanistic and clinical evidence supporting the use of targeted probiotic interventions as a strategy to improve sleep quality, buffer stress responses, and maintain microbiota homeostasis during short-term travel. By integrating microbiome, physiological, and psychological data, the findings are expected to contribute to the development of personalized, mechanism-based approaches for promoting health and resilience in the context of modern travel.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Daily one sachet containing maltodextrin
ProbioticDietary supplement
Daily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily one sachet containing maltodextrin Receives: Dietary Supplement: Placebo |
| Probiotic | Active comparator | Daily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier Receives: Dietary Supplement: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed via questionnaire
Changes in sleep quality from generally healthy adults during short-term travel following probiotic intervention compared with placebo, via the Pittsburgh Sleep Quality Index (PSQI) questionnaire, scale 0-3 where higher scores indicate poorer sleep quality.
Measured: 10-days
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed using wearable device monitoring.
Changes in sleep- and cardiac-related physiological parameters from generally healthy adults during short-term travel following probiotic intervention compared with placebo as assessed using the Huawei Band 10 NFC edition.
Measured: 10-days
Secondary outcomes (5)
General well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire
Differences in general well being using the World Health Organization Five Well-Being Index (WHO-5), having a scale of 0-5 where higher scores indicate better well being, upon administration of probiotic compared to placebo.
Measured: 10-days
Psychological well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire
Differences in psychological well being using the Depression, Anxiety and Stress Scale - 42 items (DASS-42), having a scale of 0-3 where higher scores indicate more severe depression, anxiety, or stress symptoms, upon administration of probiotic compared to placebo.
Measured: 10-days
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic or placebo as assessed via metagenomics sequencing.
Differences in microbiota abundance in fecal sample of generally healthy adults upon administration of probiotic compared to placebo.
Measured: 10-days
Gastrointestinal immune biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)
Differences in concentrations of gastrointestinal immune biomarkers upon administration of probiotic compared to placebo such as calprotectin using Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: 10-days
Salivary stress biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)
Differences in concentrations of salivary stress biomarkers upon administration of probiotic compared to placebo such as cortisol using Enzyme-Linked Immunosorbent Assay (ELISA)
Measured: 10-days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2026
- Study start1 Jul 2026 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07511855
- Sponsor's protocol ID
- HK-2526-FSN-155
- Status last verified
- Jul 2026
- First submitted
- 30 Mar 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel: A Randomized, Double-blind, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT07511855
- Acronym / sponsor ID
- HK-2526-FSN-155
- Conditions
- Healthy
- Keywords
- probiotic, Bifidobacterium, short term travel, sleep, gut microbiota
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 6 Apr 2026 (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.
This study aims to evaluate the effects of a dual Bifidobacterium longum probiotic formulation (dipro-O and dipro-X) on sleep quality, stress responses, and gut microbiota stability in healthy adults during short-term travel. Using a randomized, double-blind, placebo-controlled design, the study investigates whether probiotic supplementation can enhance sleep resilience, buffer stress, and modulate microbiome and physiological responses under travel-related environmental changes.
Detailed description
With increasing global mobility, short-term travel has become a common aspect of modern life. However, rapid environmental transitions, including changes in time zones, diet, daily routines, and psychosocial stress, can disrupt physiological homeostasis. Among the most affected systems are sleep regulation, stress responses, and gut microbiota composition. Travel-related circadian misalignment and psychological stress are known to impair sleep quality, while dietary shifts and environmental exposure can alter gut microbial balance, potentially leading to gastrointestinal discomfort, immune dysregulation, and reduced overall well-being.
Emerging evidence highlights the central role of the gut-brain axis in mediating interactions between microbiota, stress, and sleep. Alterations in gut microbiota can influence neuroendocrine pathways, including the hypothalamic-pituitary-adrenal (HPA) axis, as well as neurotransmitter systems involved in sleep and mood regulation. Consequently, maintaining microbiota stability during periods of acute stress, such as travel, may be critical for preserving both physiological and psychological resilience.
Probiotics have gained increasing attention as a potential strategy to support health under such conditions. Defined as live microorganisms that confer health benefits when administered in adequate amounts, probiotics, particularly strains within the Bifidobacterium genus, have been shown to modulate gut microbiota composition, enhance barrier function, regulate immune responses, and influence neuroendocrine signaling. Certain Bifidobacterium longum strains have demonstrated beneficial effects on stress reduction, sleep quality, and emotional regulation, suggesting their potential role in mitigating travel-related disturbances.
In this study, a dual-strain formulation containing Bifidobacterium longum subsp. longum dipro-O and dipro-X is employed, selected for their potential synergistic effects on microbiota modulation and stress resilience. These strains are hypothesized to support gut microbial stability, regulate stress-related biomarkers such as cortisol and salivary α-amylase, and improve sleep-related outcomes through modulation of neuroendocrine and microbial pathways.
To comprehensively evaluate these effects, the study integrates clinical, physiological, and multi-omics approaches. Sleep quality is assessed using both subjective (PSQI) and objective (wearable-derived) measures, while psychological status is evaluated using validated questionnaires (DASS-42, WHO-5). Biological samples, including saliva and feces, are collected to assess stress biomarkers, immune and inflammatory markers, and gut microbiota composition and function using metagenomic sequencing.
Importantly, the study adopts a longitudinal design encompassing pre-travel, travel, and post-travel phases, allowing for the assessment of dynamic changes and recovery patterns. This approach enables evaluation of not only the immediate effects of probiotic supplementation but also its potential to enhance resilience and facilitate recovery following environmental stress.
Overall, this study aims to provide mechanistic and clinical evidence supporting the use of targeted probiotic interventions as a strategy to improve sleep quality, buffer stress responses, and maintain microbiota homeostasis during short-term travel. By integrating microbiome, physiological, and psychological data, the findings are expected to contribute to the development of personalized, mechanism-based approaches for promoting health and resilience in the context of modern travel.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboDaily one sachet containing maltodextrin |
| Probiotic | Active comparator | Dietary Supplement: ProbioticDaily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Willing to participate in this study and able to provide written informed consent before any study procedures are initiated.
- Able and willing to comply with all study procedures as required by the protocol, including continuous wearable device use, saliva and stool sample collection, and completion of questionnaire assessments.
- Willing to accept randomization and group allocation as determined by the study protocol.
Key exclusion criteria (8 listed)
- Known use of antibiotics or systemic corticosteroids within 4 weeks prior to enrollment.
- Use of probiotic supplements within 4 weeks prior to enrollment.
- Planned use of any probiotic supplements during the study period.
- Known history or current presence of major endocrine disorders, active inflammatory bowel disease or other severe gastrointestinal diseases, or severe sleep disorders requiring treatment adjustment.
- Pregnant or intend to get pregnant, or lactating women.
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 |
|---|---|---|
| PlaceboDaily one sachet containing maltodextrin | Dietary supplement | Placebo |
| ProbioticDaily one sachet containing Bifidobacterium longum subsp. longum dipro-O and Bifidobacterium longum subsp. longum dipro-X, with a combined total dose of 5 × 10⁹colony-forming units (CFU) and maltodextrin as carrier | Dietary supplement | Probiotic |
Primary outcome
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed via questionnaire
Time frame: 10-days
Changes in sleep quality from generally healthy adults during short-term travel following probiotic intervention compared with placebo, via the Pittsburgh Sleep Quality Index (PSQI) questionnaire, scale 0-3 where higher scores indicate poorer sleep quality.
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed using wearable device monitoring.
Time frame: 10-days
Changes in sleep- and cardiac-related physiological parameters from generally healthy adults during short-term travel following probiotic intervention compared with placebo as assessed using the Huawei Band 10 NFC edition.
5 secondary outcomes
General well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire
Time frame: 10-days
Psychological well being in generally healthy adults upon administration of probiotic or placebo as assessed using questionnaire
Time frame: 10-days
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic or placebo as assessed via metagenomics sequencing.
Time frame: 10-days
Gastrointestinal immune biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: 10-days
Salivary stress biomarkers in generally healthy adults upon administration of probiotic or placebo as assessed using Enzyme-Linked Immunosorbent Assay (ELISA)
Time frame: 10-days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- 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.
Jie Yuan, M.Sc. contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Healthy, run by Min-Tze LIONG at 1 site in Hong Kong.
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 3 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: opening soon, as of the sponsor's last update on 9 Jul 2026. 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 Hong Kong. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Daisy Zhao, Ph.D. (3400 8680, daisydy.zhao@polyu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed via questionnaire (time frame: 10-days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.