Probiotics to prevent gut and sleep problems during short overseas trips
Effect of Probiotic Intervention on Travel-Related Health Conditions During Short-Term Overseas Travel
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
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Haidian, Beijing Municipality and 1 other locations) |
| Trial ID | NCT07163819 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Haidian, Beijing Municipality and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.