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.
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.
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.
Parallel
Placebo
Dietary supplementDaily one sachet containing maltodextrin
Probiotic
Dietary supplementDaily 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
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.
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.
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.
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.
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.
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)
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Min-Tze LIONG
Lead sponsor
Universiti Sains Malaysia
Sponsor institution
The Hong Kong Polytechnic University
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
