Healthy Adult VolunteerPhase 2NCT07182500
The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road
A Phase 2 study testing Probiotic in people with Healthy Adult Volunteer, run by Universiti Sains Malaysia at 2 sites in 2 countries.
Trial summary
Journeying along the historic Silk Road exposes travelers to dramatic dietary shifts, unfamiliar microbial environments, and the physical stresses of long-distance travel-all known to disrupt gut health and cause gastrointestinal complaints, including traveler's diarrhea and sleep disturbances. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adult Volunteer
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 16 Oct 2025to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site, 1 recruiting
- Recruiting
Shanghai Jiao Tong University School of Medicine
Huangpu, Shanghai Municipality, 200001
Meiqin Cai, MD., 86 62785846, caimeiqin@sjtu.edu.cn
peanut.yuan@diprobio.com
Malaysia1 site, 1 recruiting
- Not yet recruiting
Universiti Sains Malaysia
George Town, Pulau Pinang, 11800
Min Tze Liong, Ph.D., 6046532114, mintze.liong@usm.my
Yuan Jie, M.Sc., peanut.yuan@diprobio.com
About this study
Journeying along the historic Silk Road exposes travelers to dramatic dietary shifts, unfamiliar microbial environments, and the physical stresses of long-distance travel-all known to disrupt gut health and cause gastrointestinal complaints, including traveler's diarrhea and sleep disturbances. Such disruptions may also elevate the risk of acquiring antibiotic-resistant organisms.
This randomized, double-blind, placebo-controlled trial evaluated whether probiotic supplementation can help maintain gut microbial balance and support traveler well-being during trips to Silk Road regions. In addition to monitoring changes in gut microbiota composition, the study assessed gastrointestinal symptoms, sleep quality, anxiety levels, overall well-being, gut immune markers, functional profiles of the microbiome, and the presence of antibiotic resistance genes.
Read the detailed description
Journeys along the Silk Road-with their unique dietary shifts, unfamiliar water and food sources, novel microbial exposures, altered sleep patterns, and psychological adjustments-can significantly disrupt gut microbiota and impact overall health. Prior research has shown that even short-term travel can lead to substantial fluctuations in gut microbial composition, often accompanied by gastrointestinal symptoms and reduced well-being, underscoring the need for effective strategies to support gut homeostasis during such journeys.
Gastrointestinal distress, including traveler's diarrhea and non-diarrheal symptoms such as abdominal pain and irregular bowel movements, remains a common challenge. These issues can considerably diminish the travel experience. Furthermore, travel has been linked to an elevated risk of acquiring antimicrobial resistance genes, with the gut serving as a potential site for the exchange and amplification of resistant organisms.
Sleep disruptions-stemming from changes in routine and environment-also play an important role in traveler well-being. The gut-brain axis provides a mechanism through which sleep quality may influence gastrointestinal vulnerability, highlighting the interconnected nature of these systems.
Probiotics represent a promising intervention to support travelers. These beneficial microorganisms may enhance gut barrier function, modulate immune activity, inhibit pathogens, and produce metabolites that contribute to both gut and systemic health. Although some studies suggest probiotics can alleviate gastrointestinal symptoms and reduce the risk of diarrhea, robust evidence specific to the Silk Road travel context remains limited.
In this randomized, double-blind, placebo-controlled trial, effects of daily probiotic supplementation on gut microbiota stability, gastrointestinal symptoms, sleep quality, anxiety, and overall well-being in adults traveling the Silk Road will be evaluated. Immune markers, microbial functional pathways, and antibiotic resistance gene profiles will be identified to better understand the potential mechanisms of action. The investigators hypothesized that probiotic intake would help maintain microbial balance, reduce travel-related symptoms, and support physical and emotional well-being throughout the journey.
- Conditions
- Healthy Adult Volunteer
- Being tested
- Probiotic, Placebo
- Keywords
- probiotc, travel, Silk Road
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Daily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)
PlaceboOther
Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil Receives: Other: Placebo |
| Probiotic | Experimental | Daily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day) Receives: Other: Probiotic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing
Differences in microbiota abundance in fecal sample of generally healthy adults upon administration of probiotic as compared to placebo
Measured: 7 days
Secondary outcomes (7)
Respiratory symptoms duration and frequency in generally healthy adults upon administration of probiotic as assessed using questionnaire
Changes in duration and frequency of respiratory illnesses symptoms from generally healthy adults on probiotic or placebo after 7-days, via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms
Measured: 7 days
Gastrointestinal symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in duration and frequency of gastrointestinal symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms
Measured: 7 days
Allergy symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in duration and frequency of allergy symptoms upon administration of probiotic compared to placebo via the use of standard clinical assessment questionnaire, scale 0-3 where higher scores indicate more severe symptoms
Measured: 7 days
Gastrointestinal metabolites in generally healthy adults upon administration of probiotic as assessed using LC-MS
Differences in concentrations of gastrointestinal metabolites upon administration of probiotic compared to placebo
Measured: 7 days
Anxiety in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in anxiety via the GAD-7 questionnaire （scale 0-3 where higher scores indicate more severe outcomes), upon administration of probiotic compared to placebo
Measured: 7 days
Sleep quality in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in sleep quality via the PSQI questionnaire （scale 0-3 where higher scores indicate more severe outcomes) upon administration of probiotic compared to placebo
Measured: 7 days
Well-being in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in well-being via the WHO-5 questionnaire (scale 0-5 where higher scores indicate better outcomes）upon administration of probiotic compared to placebo
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start16 Oct 2025
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adult VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universiti Sains Malaysia
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Responsible party
- Principal investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Meiqin Cai, MD., Principal investigator, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182500
- Sponsor's protocol ID
- SJUPN-2025-013-HY1-KS2
- Status last verified
- Dec 2025
- First submitted
- 8 Sep 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Bifidobacterium Probiotics on Gut Microbiota Changes in Healthy Adults During Short-term Travel Along the Silk Road
- ClinicalTrials.gov ID
- NCT07182500
- Acronym / sponsor ID
- SJUPN-2025-013-HY1-KS2
- Conditions
- Healthy Adult Volunteer
- Keywords
- probiotc, travel, Silk Road
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Universiti Sains MalaysiaUniversity, hospital or other
- Collaborators
- Shanghai Jiao Tong University School of Medicine
- Study start
- 16 Oct 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 19 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Journeying along the historic Silk Road exposes travelers to dramatic dietary shifts, unfamiliar microbial environments, and the physical stresses of long-distance travel-all known to disrupt gut health and cause gastrointestinal complaints, including traveler's diarrhea and sleep disturbances. Such disruptions may also elevate the risk of acquiring antibiotic-resistant organisms.
This randomized, double-blind, placebo-controlled trial evaluated whether probiotic supplementation can help maintain gut microbial balance and support traveler well-being during trips to Silk Road regions. In addition to monitoring changes in gut microbiota composition, the study assessed gastrointestinal symptoms, sleep quality, anxiety levels, overall well-being, gut immune markers, functional profiles of the microbiome, and the presence of antibiotic resistance genes.
Detailed description
Journeys along the Silk Road-with their unique dietary shifts, unfamiliar water and food sources, novel microbial exposures, altered sleep patterns, and psychological adjustments-can significantly disrupt gut microbiota and impact overall health. Prior research has shown that even short-term travel can lead to substantial fluctuations in gut microbial composition, often accompanied by gastrointestinal symptoms and reduced well-being, underscoring the need for effective strategies to support gut homeostasis during such journeys.
Gastrointestinal distress, including traveler's diarrhea and non-diarrheal symptoms such as abdominal pain and irregular bowel movements, remains a common challenge. These issues can considerably diminish the travel experience. Furthermore, travel has been linked to an elevated risk of acquiring antimicrobial resistance genes, with the gut serving as a potential site for the exchange and amplification of resistant organisms.
Sleep disruptions-stemming from changes in routine and environment-also play an important role in traveler well-being. The gut-brain axis provides a mechanism through which sleep quality may influence gastrointestinal vulnerability, highlighting the interconnected nature of these systems.
Probiotics represent a promising intervention to support travelers. These beneficial microorganisms may enhance gut barrier function, modulate immune activity, inhibit pathogens, and produce metabolites that contribute to both gut and systemic health. Although some studies suggest probiotics can alleviate gastrointestinal symptoms and reduce the risk of diarrhea, robust evidence specific to the Silk Road travel context remains limited.
In this randomized, double-blind, placebo-controlled trial, effects of daily probiotic supplementation on gut microbiota stability, gastrointestinal symptoms, sleep quality, anxiety, and overall well-being in adults traveling the Silk Road will be evaluated. Immune markers, microbial functional pathways, and antibiotic resistance gene profiles will be identified to better understand the potential mechanisms of action. The investigators hypothesized that probiotic intake would help maintain microbial balance, reduce travel-related symptoms, and support physical and emotional well-being throughout the journey.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil |
| Probiotic | Experimental | Other: ProbioticDaily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticDaily 6-drops of Bifidobacterium longum subsp. infantis M-63, B. breve M-16V, and B. longum BB536 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day) | Other | Probiotic |
| PlaceboDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil | Other | Placebo |
Primary outcome
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing
Time frame: 7 days
Differences in microbiota abundance in fecal sample of generally healthy adults upon administration of probiotic as compared to placebo
7 secondary outcomes
Respiratory symptoms duration and frequency in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Gastrointestinal symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Allergy symptoms in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Gastrointestinal metabolites in generally healthy adults upon administration of probiotic as assessed using LC-MS
Time frame: 7 days
Anxiety in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Sleep quality in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Well-being in generally healthy adults upon administration of probiotic as assessed using questionnaire
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Meiqin Cai, MD. principal investigator
Shanghai Jiao Tong University School of Medicine
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Probiotic in people with Healthy Adult Volunteer, run by Universiti Sains Malaysia at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Min Tze Liong, Ph.D. (6046532114, mintze.liong@usm.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbiota profiles of fecal samples in generally healthy adults upon administration of probiotic as assessed via metagenomics sequencing (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2025.