RecruitingPhase 2NCT07163819

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


Sponsor

Universiti Sains Malaysia

Enrollment

46 participants

Start Date

Jul 31, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

  • 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 Criteria7

  • 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

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Interventions

OTHERProbiotic

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)

OTHERPlacebo

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


Locations(2)

Tsinghua University Science and Technology

Haidian, Beijing Municipality, China

Universiti Sains Malaysia

George Town, Pulau Pinang, Malaysia

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NCT07163819


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