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Not Yet Recruiting 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07511855). StuddyBuddy aggregates publicly available trial information.