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NCT07511855
Stress-buffering and Sleep Disturbance-resilient Effects of a Dual Bifidobacterium Longum Combination Under Short-term Travel
Conditions: Healthy
Sex: All
Ages: 25 Years – 50 Years
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 60
Sponsor: Min-Tze LIONG
Location: The Hong Kong Polytechnic University Kowloon Kowloon
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07511855). StuddyBuddy aggregates publicly available trial information.