Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combina… (NCT07511855) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel
Hong Kong60 participantsStarted 2026-04-01
Plain-language 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. 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.
Who can participate
Age range
25 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed via questionnaire
Timeframe: 10-days
2
Sleep quality during short-term travel following probiotic intervention compared with placebo as assessed using wearable device monitoring.