Effect of Probiotic Intervention on Travel-Related Health Conditions During Short-Term Overseas Travel

NCT07163819 · tracked via the Priya Life Science China tracker

Sponsor

Universiti Sains Malaysia

Phase

Phase 2

Started

2025-07-31

Last updated

2025-09-17

Condition(s) studied

Healthy Adults

Investigational drug(s) / intervention(s)

ProbioticPlacebo

Probiotic: Daily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)

Placebo: Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil

Study summary

International travel disrupts gut health through dietary changes, microbial exposure, and stress, often causing gastrointestinal symptoms like traveler's diarrhea and sleep disturbances. These shifts may increase antibiotic resistance risks. Probiotics may help stabilize gut microbiota and improve well-being during travel. This randomized, double-blind, placebo-controlled trial investigated whether probiotic supplementation mitigates gut microbiota perturbations, gastrointestinal symptoms, and sleep issues in adults traveling abroad. The investigators also assessed changes in anxiety, well-being, gut immunity, microbial function, and antibiotic resistance genes.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: * Generally healthy adults * Scheduled to undertake a short-term round trip (less than 7 days) to abroad * Able to complete study procedures * Willing to take intervention products Exclusion Criteria: * Use of antibiotics, probiotics, hormones, immunosuppressants, biologics or JAK inhibitors within four weeks prior to study * Chronic or severe systemic diseases (including cardiovascular, hepatic, renal, malignant or psychiatric disorders) * Uncontrolled parasitic infections * Long-term use of corticosteroids, growth hormone, vitamin B12, lysine or inositol * Major surgery within one month * Allergy to probiotic components * Other conditions deemed inappropriate by investigators

Primary outcome measure(s)

Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing — 7 days
Differences in microbiota abundance in fecal sample of generally healthy adults upon administration o probiotic compared to placebo

Trial sites (2)

Facility	City	Region	Status
Tsinghua University Science and Technology	Haidian	Beijing Municipality	Recruiting
Universiti Sains Malaysia	George Town	Pulau Pinang	Not Yet Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07163819 on ClinicalTrials.gov ↗ ← All trials in China