Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 65

Probiotics to prevent gut and sleep problems during short overseas trips

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

Run by Universiti Sains Malaysia · NCT07163819 · Data updated 2026-11-12

This trial will try a probiotic versus placebo in healthy adults traveling abroad for less than a week to see if it reduces gut symptoms, sleep disruption, and microbiome changes.

Quick facts

PhasePhase 2
Study typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment46 (estimated)
SponsorUniversiti Sains Malaysia
Academic / other
Locations2 sites (Haidian, Beijing Municipality and 1 other locations)
StatusRecruiting
StartedJuly 31, 2025
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedSeptember 17, 2025
Trial IDNCT07163819 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Healthy adults planning a short (less than 7 days) round-trip international trip who can attend study visits and have not used antibiotics or probiotics in the prior four weeks are ideal candidates.

Probably not a fit

People with chronic or severe systemic illnesses, recent antibiotic or probiotic use, long-term immunosuppressive or excluded medications, allergies to probiotic ingredients, or inability to complete study procedures are unlikely to benefit from participation.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, placebo-controlled Phase 2 trial gives healthy adults either a probiotic or matching placebo before and during a short (under 7 days) round-trip overseas journey. Investigators collect stool samples and symptom, sleep, and well-being data before, during, and after travel to measure changes in gut microbiota composition, gut immunity markers, microbial function, and antibiotic-resistance genes. The study excludes people with recent antibiotic or probiotic use, major chronic disease, certain long-term medications, or allergies to probiotic components. Outcomes compare symptom rates, sleep and anxiety measures, and microbiome and resistance-gene changes between the probiotic and placebo groups.

Why it matters

Potential benefit: If successful, the probiotic could reduce travel-related gastrointestinal symptoms and sleep disruption and help maintain a healthier gut microbiome during short overseas trips.

How similar studies have gone: Previous randomized trials and meta-analyses have shown modest reductions in traveler's diarrhea and some gastrointestinal symptoms with certain probiotics, but effects on overall microbiome stability and antibiotic-resistance genes remain less certain.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Tsinghua University Science and Technology
    Haidian, Beijing Municipality, China
    Recruiting
  • Universiti Sains Malaysia
    George Town, Pulau Pinang, Malaysia
    Not yet recruiting

Study contacts

  • Principal investigator: Ai Zhou, Ph.D. — Tsinghua University Science and Technology
  • Study coordinator: Min Tze Liong, Ph.D.
  • Email: mintze.liong@usm.my
  • Phone: 6046532114

Similar studies

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.