Bifidobacterium probiotic to support gut health during short Silk Road trips
The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road
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 |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universiti Sains Malaysia Academic / other |
| Locations | 2 sites (Huangpu, Shanghai Municipality and 1 other locations) |
| Trial ID | NCT07182500 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
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
Huangpu, Shanghai Municipality and 1 other locations
- 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
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.