Healthy AdultPhase 2The Effect ofNCT07384260
The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial
A Phase 2 study testing Probiotic in people with Healthy Adult, run by Min-Tze LIONG at 2 sites in 2 countries.
Trial summary
This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to… 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
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Feb 2026to 31 Jan 2027
- 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
- Aged 18-65 years, regardless of gender;
- Planning to undertake a short-term round-trip journey to Europe (within 7 days);
- Able to understand and willing to comply with the study protocol, and to cooperate with study procedures;
- Voluntarily sign the informed consent form before any study-related procedures are initiated.
Who cannot join
- Diseases that may affect the evaluation of trial results, such as immune dysfunction, severe renal/hepatic dysfunction, severe cardiovascular disease, malignant tumors, acute or chronic infections, etc.;
- Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks;
- Subjects with diagnosed or uncontrolled parasitic infections;
- Patients receiving long-term medication for chronic diseases;
- Patients with severe organic lesions in the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system;
- Patients with a history of or currently diagnosed mental illness;
Show all 13Show fewer
- Patients on long-term corticosteroid therapy;
- Use of growth hormone, γ-aminobutyric acid (GABA), lysine, inositol, or vitamin B12;
- Presence of uncontrolled, clinically significant laboratory abnormalities that may affect data interpretation or subject participation;
- Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 4 weeks;
- Presence of severe infections or major trauma deemed by the investigator to potentially affect outcomes, or having undergone moderate to major surgery within the past month;
- Known allergy to any component of the probiotic product;
- Subjects deemed unsuitable for participation by the investigator for any other reason.
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
Tsinghua University Science and Technology
Haidian, Beijing Municipality, 100080
Yuan Jie, M.Sc., 822137027899, peanut.yuan@diprobio.com
Malaysia1 site
Universiti Sains Malaysia
Pulau Pinang, Pulau Pinang, 11800
Min Tze Liong, Ph.D, 6046532114, mintze.liong@usm.my
About this study
This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to Europe.
Read the detailed description
With rising living standards, travel has become a common leisure activity. However, environmental changes, altered dietary habits, and disruptions to circadian rhythms during travel can significantly affect gut microbiota, potentially leading to various health issues. Dietary shifts are a primary driver of these alterations; the introduction of unfamiliar foods and beverages exposes the gut to foreign bacterial strains that compete with indigenous microbiota, increasing the risk of dysbiosis. This imbalance may manifest as gastrointestinal disturbances such as traveler's diarrhea or constipation, often associated with high-fat and low-fiber diets. In addition to dietary factors, travel-related stress, jet lag, and variations in hygiene conditions further influence microbial homeostasis. Growing evidence underscores a close relationship between gut microbiota and immune function, indicating that dysbiosis may compromise immune defenses and heighten susceptibility to respiratory infections and allergic responses triggered by novel environmental exposures.
Probiotics, defined as live microorganisms that confer health benefits when administered in adequate amounts, have gained considerable attention for their potential to promote human health. Predominantly derived from the *Lactobacillus* and *Bifidobacterium* genera, these beneficial microbes support gut health by modulating microbial composition, enhancing immune function, and improving digestive processes. Numerous studies have demonstrated their effectiveness in alleviating gastrointestinal disorders and reducing infection risk through immune system reinforcement. In addition, the capacity of probiotics to influence the gut-brain axis highlights their potential role in supporting mental health.
To ensure both safety and efficacy, this study employs *Bifidobacterium animalis* subsp. *lactis* B94 and *Lacticaseibacillus helveticus* R0052. Strain B94 has been clinically validated for improving bowel regularity and alleviating gastrointestinal discomfort through mechanisms such as short-chain fatty acid (SCFA) production, pathogen inhibition, and enhancement of intestinal barrier function. Strain R0052 is well recognized for its tolerability and its ability to shorten the duration of antibiotic-associated diarrhea while modulating immune responses. Moreover, R0052 has been shown to reduce psychological distress under stressful conditions, suggesting a regulatory role within the gut-brain axis. The combined use of these strains is therefore expected to promote microbiota stability and support overall health during the short-term physiological and psychological stress associated with travel.
The present study builds upon findings from a previous randomized controlled trial involving travelers to Japan. That trial demonstrated that short-term probiotic supplementation significantly enhanced gut microbiota resilience and improved both physiological and psychological homeostasis. Compared with the control group, participants receiving probiotics exhibited smaller fluctuations in microbial composition and achieved a more rapid return to baseline following travel. Lower incidences of gastrointestinal discomfort were reported, alongside improvements in anxiety, fatigue, and mood stability. Collectively, these results suggest that short-term probiotic intervention represents a practical and effective strategy for supporting health and well-being during periods of rapid environmental and lifestyle change.
- Conditions
- Healthy Adult
- Being tested
- Placebo, Probiotic
- Keywords
- probiotic, international travel
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboOther
Daily 6-drops of non-GMO corn starch in medium-chain triglyceride oil
ProbioticOther
Daily 6-drops of Bifidobacterium animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day)
| 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 animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 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 o probiotic compared to placebo
Measured: 7 days
Secondary outcomes (6)
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
Anxiety in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in anxiety using the Generalized Anxiety Disorder Scale (GAD-7), having a scale of 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 using the Pittsburgh Sleep Quality Index (PSQI), having a scale of 0-3 where higher scores indicate more severe outcomes, upon administration of probiotic compared to placebo.
Measured: 7 days
General well being in generally healthy adults upon administration of probiotic as assessed using questionnaire
Differences in general well being using the World Health Organization Five Well-Being Index (WHO-5), having a scale of 0-5 where higher scores indicate better well being, 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 posted3 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Jan 2027 (estimated)
- Study completion31 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy AdultStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Min-Tze LIONG
- Sponsor type
- University, hospital or other
- Collaborators
- Tsinghua University
- Responsible party
- Sponsor-investigator, Min-Tze LIONG, Universiti Sains Malaysia
- Investigators
- Ai Zhou, Ph.D., Principal investigator, Tsinghua University Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07384260
- Sponsor's protocol ID
- THU-01-2025-1092
- Acronym
- The Effect of
- Status last verified
- Jan 2026
- First submitted
- 19 Jan 2026
- Last updated
- 3 Feb 2026
- 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 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Probiotics on Gut Microbiota Changes in Healthy Chinese Adults During Short-Term European Travel: A Randomised, Double-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07384260
- Acronym / sponsor ID
- The Effect of / THU-01-2025-1092
- Conditions
- Healthy Adult
- Keywords
- probiotic, international travel
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Min-Tze LIONGUniversity, hospital or other
- Collaborators
- Tsinghua University
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Jan 2027 (estimated)
- Study completion
- 31 Jan 2027 (estimated)
- First posted
- 3 Feb 2026 (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.
This study aims to evaluate the efficacy of a probiotic complex (containing Bifidobacterium animalis subsp. lactis B94 and Lacticaseibacillus helveticus R0052) in maintaining gut microbiota homeostasis and supporting physiological and psychological stability among healthy Chinese adults during short-term travel to Europe.
Detailed description
With rising living standards, travel has become a common leisure activity. However, environmental changes, altered dietary habits, and disruptions to circadian rhythms during travel can significantly affect gut microbiota, potentially leading to various health issues. Dietary shifts are a primary driver of these alterations; the introduction of unfamiliar foods and beverages exposes the gut to foreign bacterial strains that compete with indigenous microbiota, increasing the risk of dysbiosis. This imbalance may manifest as gastrointestinal disturbances such as traveler's diarrhea or constipation, often associated with high-fat and low-fiber diets. In addition to dietary factors, travel-related stress, jet lag, and variations in hygiene conditions further influence microbial homeostasis. Growing evidence underscores a close relationship between gut microbiota and immune function, indicating that dysbiosis may compromise immune defenses and heighten susceptibility to respiratory infections and allergic responses triggered by novel environmental exposures.
Probiotics, defined as live microorganisms that confer health benefits when administered in adequate amounts, have gained considerable attention for their potential to promote human health. Predominantly derived from the *Lactobacillus* and *Bifidobacterium* genera, these beneficial microbes support gut health by modulating microbial composition, enhancing immune function, and improving digestive processes. Numerous studies have demonstrated their effectiveness in alleviating gastrointestinal disorders and reducing infection risk through immune system reinforcement. In addition, the capacity of probiotics to influence the gut-brain axis highlights their potential role in supporting mental health.
To ensure both safety and efficacy, this study employs *Bifidobacterium animalis* subsp. *lactis* B94 and *Lacticaseibacillus helveticus* R0052. Strain B94 has been clinically validated for improving bowel regularity and alleviating gastrointestinal discomfort through mechanisms such as short-chain fatty acid (SCFA) production, pathogen inhibition, and enhancement of intestinal barrier function. Strain R0052 is well recognized for its tolerability and its ability to shorten the duration of antibiotic-associated diarrhea while modulating immune responses. Moreover, R0052 has been shown to reduce psychological distress under stressful conditions, suggesting a regulatory role within the gut-brain axis. The combined use of these strains is therefore expected to promote microbiota stability and support overall health during the short-term physiological and psychological stress associated with travel.
The present study builds upon findings from a previous randomized controlled trial involving travelers to Japan. That trial demonstrated that short-term probiotic supplementation significantly enhanced gut microbiota resilience and improved both physiological and psychological homeostasis. Compared with the control group, participants receiving probiotics exhibited smaller fluctuations in microbial composition and achieved a more rapid return to baseline following travel. Lower incidences of gastrointestinal discomfort were reported, alongside improvements in anxiety, fatigue, and mood stability. Collectively, these results suggest that short-term probiotic intervention represents a practical and effective strategy for supporting health and well-being during periods of rapid environmental and lifestyle change.
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 animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 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)
- Aged 18-65 years, regardless of gender;
- Planning to undertake a short-term round-trip journey to Europe (within 7 days);
- Able to understand and willing to comply with the study protocol, and to cooperate with study procedures;
- Voluntarily sign the informed consent form before any study-related procedures are initiated.
Key exclusion criteria (13 listed)
- Diseases that may affect the evaluation of trial results, such as immune dysfunction, severe renal/hepatic dysfunction, severe cardiovascular disease, malignant tumors, acute or chronic infections, etc.;
- Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks;
- Subjects with diagnosed or uncontrolled parasitic infections;
- Patients receiving long-term medication for chronic diseases;
- Patients with severe organic lesions in the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system;
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 |
|---|---|---|
| PlaceboDaily 6-drops of non-GMO corn starch in medium-chain triglyceride oil | Other | Placebo |
| ProbioticDaily 6-drops of Bifidobacterium animalis subsp. lactis B94, Lacticaseibacillus helveticus R0052 in non-GMO corn starch as excipient, in medium-chain triglyceride oil (1.5 × 109 CFU/day) | Other | Probiotic |
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 o probiotic compared to placebo
6 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
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
General 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 3 Feb 2026.
- 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.
Ai Zhou, Ph.D. principal investigator
Tsinghua University Science and Technology
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, run by Min-Tze LIONG 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 13 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: opening soon, as of the sponsor's last update on 3 Feb 2026. 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 Yuan Jie, M.Sc. (822137027899, peanut.yuan@diprobio.com), 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 3 Feb 2026.