Bifidobacterium probiotic to support gut health during short Silk Road trips
Official title: The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road
Run by Universiti Sains Malaysia · NCT07182500 · Data updated 2026-11-12
This trial will try whether taking a Bifidobacterium probiotic helps healthy adults keep their gut microbiome stable and reduce digestive and sleep problems during short trips along the Silk Road.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Huangpu, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | October 16, 2025 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | December 10, 2025 |
| Trial ID | NCT07182500 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are generally healthy adults planning a short (<7 day) round-trip abroad who can follow study procedures and are willing to take the assigned supplement.
✕Probably not a fit
People with recent antibiotic or probiotic use, chronic severe systemic diseases, immunosuppression, or allergies to probiotic components are unlikely to benefit or may be excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, double-blind, placebo-controlled Phase 2 trial in generally healthy adults planning short round-trip travel abroad. Participants receive either a Bifidobacterium probiotic or a matching placebo around the time of travel. Researchers collect stool and questionnaire data to track gut microbiota composition, gastrointestinal symptoms, sleep quality, anxiety, well-being, gut immune markers, microbiome functional profiles, and antibiotic resistance genes. The trial compares changes from baseline between the probiotic and placebo groups to see if the probiotic preserves microbial balance and traveler well-being.
Why it matters
Potential benefit: If successful, the probiotic could reduce travel-related gut disturbances, improve sleep and comfort during short trips, and lower the chance of picking up antibiotic-resistance genes in the gut.
How similar studies have gone: Previous trials of probiotics for travel-related gastrointestinal symptoms and microbiome stability have shown mixed but sometimes positive results, so this approach has partial supporting evidence.
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
-
Shanghai Jiao Tong University School of Medicine
Huangpu, Shanghai Municipality, China Recruiting -
Universiti Sains Malaysia
George Town, Pulau Pinang, Malaysia Not yet recruiting
Study contacts
- Principal investigator: Meiqin Cai, MD. — Shanghai Jiao Tong University School of Medicine
- Study coordinator: Min Tze Liong, Ph.D.
- Email: mintze.liong@usm.my
- Phone: 6046532114
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.