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Recruiting Phase 2 NCT07163819

NCT07163819 Effect of Probiotic Intervention on Travel-Related Health Conditions During Short-Term Overseas Travel

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Clinical Trial Summary
NCT ID NCT07163819
Status Recruiting
Phase Phase 2
Sponsor Universiti Sains Malaysia
Condition Healthy Adults
Study Type INTERVENTIONAL
Enrollment 46 participants
Start Date 2025-07-31
Primary Completion 2025-12-31

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
ProbioticPlacebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.

This trial targets 46 participants in total. It began in 2025-07-31 with a primary completion date of 2025-12-31.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief 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 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

Contact & Investigator

Central Contact

Min Tze Liong, Ph.D.

✉ mintze.liong@usm.my

📞 6046532114

Principal Investigator

Ai Zhou, Ph.D.

PRINCIPAL INVESTIGATOR

Tsinghua University Science and Technology

Frequently Asked Questions

Who can join the NCT07163819 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Healthy Adults. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT07163819 trial and what does that mean for participants?

Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.

Is NCT07163819 currently recruiting?

Yes, NCT07163819 is actively recruiting participants. Contact the research team at mintze.liong@usm.my for enrollment information.

Where is the NCT07163819 trial being conducted?

This trial is being conducted at Haidian, China, George Town, Malaysia.

Who is sponsoring the NCT07163819 clinical trial?

NCT07163819 is sponsored by Universiti Sains Malaysia. The principal investigator is Ai Zhou, Ph.D. at Tsinghua University Science and Technology. The trial plans to enroll 46 participants.

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