Changes in Gut Microbiota, Gut Metabolites, Respiratory Symptoms, and Well-being IndexNCT07705659
A Probiotic for Health Outcomes in Short-Term Overseas Travel
A study testing Bifidobacterium longum and Maltodextrin in people with Changes in Gut Microbiota, Gut Metabolites, Respiratory Symptoms, and Well-being Index, run by DiproBio (Shanghai) Co., Ltd..
Trial summary
With the improvement of living standards, travel has become a common form of leisure. However, travelers often face changes in living environments, dietary habits, and sleep schedules, all of which can impact the gut microbiota and lead to a range of health issues. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Changes in Gut Microbiota, Gut Metabolites, Respiratory Symptoms, and Well-being Index
- What is being tested?
- Bifidobacterium longum and Maltodextrin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 30 Jul 2026to 31 Mar 2027
- Phase
- Interventional
- 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
- Age: 18-65 years, inclusive, with no restriction on gender.
- Planned short-term round-trip travel from China to an overseas destination, with a total travel duration of no more than 7 days.
- Volunteers must be able to understand and comply with the study protocol, and provide written informed consent prior to initiation of any study procedures.
Who cannot join
- Diseases that may affect the evaluation of trial results, including but not limited to immune dysfunction, severe renal/hepatic impairment, 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 prior to enrollment.
- Subjects with confirmed or uncontrolled parasitic infections.
- ① Patients receiving long-term medication for chronic diseases; ② Patients with severe organic lesions of the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system; ③ Patients with a history of or current psychiatric disorders; ④ Patients on long-term glucocorticoid therapy; ⑤ Patients using growth hormone, γ-aminobutyric acid, lysine, inositol, or vitamin B12.
- Any uncontrolled, clinically significant laboratory abnormalities that, in the opinion of the investigator, may interfere with the interpretation of study data or the subject's ability to participate in the study.
- Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 4 weeks.
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- Subjects with severe infection or severe trauma as determined by the investigator, or those who have undergone moderate to major surgery within the past month.
- Known allergy to any components of the probiotic product.
- Subjects deemed unsuitable for participation in this clinical study by the investigator for any other reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Affects of a Bifidobacterium Longum Combination on Health Outcomes Associated With Short-Term Overseas Travel
With the improvement of living standards, travel has become a common form of leisure. However, travelers often face changes in living environments, dietary habits, and sleep schedules, all of which can impact the gut microbiota and lead to a range of health issues.
Dietary changes during travel are one of the key factors affecting gut microbiota. Food composition and preparation methods vary widely across regions, introducing novel bacterial strains into the gut. These new strains may compete with the host's indigenous microbiota, causing dysbiosis and gastrointestinal problems such as traveler's diarrhea. Additionally, high-fat diets and low-fiber intake can disrupt gut microbial balance, leading to constipation. Beyond diet, jet lag, stress, and hygiene conditions also influence gut microbiota. For example, frequent cross-time-zone travel disrupts the circadian rhythm of the gut microbiome, impairing the host's metabolic health. Furthermore, exposure to contaminated water or food during travel may introduce pathogenic bacteria such as Escherichia coli, Shigella, and Campylobacter, which can disrupt gut homeostasis and cause gastrointestinal infections.
Read more
Changes in gut microbiota not only affect gastrointestinal health but may also trigger respiratory and allergic symptoms. Studies have shown a close relationship between gut microbiota and the immune system; gut dysbiosis can lead to immune dysfunction, increasing the risk of respiratory infections. Additionally, alterations in gut microbiota may influence allergic responses, with exposure to new environments and foods during travel potentially exacerbating allergic symptoms.
Probiotics-live microorganisms that confer health benefits to the host when administered in adequate amounts-have garnered widespread attention for their potential to enhance human health. These beneficial microbes, primarily from the genera Lactobacillus and Bifidobacterium, promote gut health by modulating the gut microbiome, supporting immune function, and improving digestion. Research indicates that probiotics can alleviate symptoms of gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease, while also enhancing overall immunity and reducing infection risk. Furthermore, their role in regulating the gut-brain axis highlights their potential to improve mental health. Therefore, rational probiotic supplementation to maintain gut microbiota balance is of great significance for promoting human health.
This study aims to evaluate the efficacy of probiotics in maintaining gut microbial balance and improving health outcomes during short-term travel. By assessing microbial composition, immune markers (e.g., sIgA), respiratory symptoms, allergic and gastrointestinal symptoms, anxiety disorders, sleep quality, and well-being indices, the study seeks to demonstrate the benefits of probiotic supplementation in mitigating travel-related health issues.
- Being tested
- Bifidobacterium longum, Maltodextrin
- Medical subject headings
- Signs and Symptoms, Respiratory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bifidobacterium longumDietary supplement
The intervention period begins on the day of travel departure. Subjects take one sachet of the investigational product orally per day until the end of their trip. Each sachet in the probiotic intervention group contains approximately 5 × 10⁹ CFU of Bifidobacterium longum subsp. longum dipro-O plus Bifidobacterium longum subsp. longum dipro-X.
MaltodextrinDietary supplement
The intervention period begins on the day of travel departure. The placebo group receives an equal amount of carrier without live bacteria.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic Intervention Group | Experimental | Not described Receives: Dietary Supplement: Bifidobacterium longum |
| Placebo Control Group | Placebo comparator | Not described Receives: Dietary Supplement: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in gut microbiota in healthy Chinese adults taking probiotic during short-term overseas travel (within 7 days) compared to placebo
Measured: Baseline (pre-travel) and post-travel (within 1 day after return)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start30 Jul 2026 (estimated)
- Primary completion28 Feb 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Gut Microbiota, Gut Metabolites, Respiratory Symptoms, and Well-being IndexStudies 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 N/A
- 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
- DiproBio (Shanghai) Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07705659
- Sponsor's protocol ID
- THU-01-2026-0068
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affects of a Bifidobacterium Longum Combination on Health Outcomes Associated With Short-Term Overseas Travel
- ClinicalTrials.gov ID
- NCT07705659
- Acronym / sponsor ID
- THU-01-2026-0068
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- DiproBio (Shanghai) Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Jul 2026 (estimated)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 15 Jul 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.
With the improvement of living standards, travel has become a common form of leisure. However, travelers often face changes in living environments, dietary habits, and sleep schedules, all of which can impact the gut microbiota and lead to a range of health issues.
Dietary changes during travel are one of the key factors affecting gut microbiota. Food composition and preparation methods vary widely across regions, introducing novel bacterial strains into the gut. These new strains may compete with the host's indigenous microbiota, causing dysbiosis and gastrointestinal problems such as traveler's diarrhea. Additionally, high-fat diets and low-fiber intake can disrupt gut microbial balance, leading to constipation. Beyond diet, jet lag, stress, and hygiene conditions also influence gut microbiota. For example, frequent cross-time-zone travel disrupts the circadian rhythm of the gut microbiome, impairing the host's metabolic health. Furthermore, exposure to contaminated water or food during travel may introduce pathogenic bacteria such as Escherichia coli, Shigella, and Campylobacter, which can disrupt gut homeostasis and cause gastrointestinal infections.
Changes in gut microbiota not only affect gastrointestinal health but may also trigger respiratory and allergic symptoms. Studies have shown a close relationship between gut microbiota and the immune system; gut dysbiosis can lead to immune dysfunction, increasing the risk of respiratory infections. Additionally, alterations in gut microbiota may influence allergic responses, with exposure to new environments and foods during travel potentially exacerbating allergic symptoms.
Probiotics-live microorganisms that confer health benefits to the host when administered in adequate amounts-have garnered widespread attention for their potential to enhance human health. These beneficial microbes, primarily from the genera Lactobacillus and Bifidobacterium, promote gut health by modulating the gut microbiome, supporting immune function, and improving digestion. Research indicates that probiotics can alleviate symptoms of gastrointestinal disorders such as irritable bowel syndrome and inflammatory bowel disease, while also enhancing overall immunity and reducing infection risk. Furthermore, their role in regulating the gut-brain axis highlights their potential to improve mental health. Therefore, rational probiotic supplementation to maintain gut microbiota balance is of great significance for promoting human health.
This study aims to evaluate the efficacy of probiotics in maintaining gut microbial balance and improving health outcomes during short-term travel. By assessing microbial composition, immune markers (e.g., sIgA), respiratory symptoms, allergic and gastrointestinal symptoms, anxiety disorders, sleep quality, and well-being indices, the study seeks to demonstrate the benefits of probiotic supplementation in mitigating travel-related health issues.
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 |
|---|---|---|
| Probiotic Intervention Group | Experimental | Dietary Supplement: Bifidobacterium longum |
| Placebo Control Group | Placebo comparator | Dietary Supplement: Maltodextrin |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 18-65 years, inclusive, with no restriction on gender.
- Planned short-term round-trip travel from China to an overseas destination, with a total travel duration of no more than 7 days.
- Volunteers must be able to understand and comply with the study protocol, and provide written informed consent prior to initiation of any study procedures.
Key exclusion criteria (9 listed)
- Diseases that may affect the evaluation of trial results, including but not limited to immune dysfunction, severe renal/hepatic impairment, 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 prior to enrollment.
- Subjects with confirmed or uncontrolled parasitic infections.
- ① Patients receiving long-term medication for chronic diseases; ② Patients with severe organic lesions of the thyroid, heart, brain, lungs, kidneys, or musculoskeletal system; ③ Patients with a history of or current psychiatric disorders; ④ Patients on long-term glucocorticoid therapy; ⑤ Patients using growth hormone, γ-aminobutyric acid, lysine, inositol, or vitamin B12.
- Any uncontrolled, clinically significant laboratory abnormalities that, in the opinion of the investigator, may interfere with the interpretation of study data or the subject's ability to participate in the study.
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 |
|---|---|---|
| Bifidobacterium longumThe intervention period begins on the day of travel departure. Subjects take one sachet of the investigational product orally per day until the end of their trip. Each sachet in the probiotic intervention group contains approximately 5 × 10⁹ CFU of Bifidobacterium longum subsp. longum dipro-O plus Bifidobacterium longum subsp. longum dipro-X. | Dietary supplement | Probiotic Intervention Group |
| MaltodextrinThe intervention period begins on the day of travel departure. The placebo group receives an equal amount of carrier without live bacteria. | Dietary supplement | Placebo Control Group |
Primary outcome
Changes in gut microbiota in healthy Chinese adults taking probiotic during short-term overseas travel (within 7 days) compared to placebo
Time frame: Baseline (pre-travel) and post-travel (within 1 day after return)
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 15 Jul 2026.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Bifidobacterium longum and Maltodextrin in people with Changes in Gut Microbiota, Gut Metabolites, Respiratory Symptoms, and Well-being Index, run by DiproBio (Shanghai) Co., Ltd..
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 3 inclusion and 9 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 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
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.
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 Ai Zhao (86-13811131994, aizhao18@mail.tsinghua.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in gut microbiota in healthy Chinese adults taking probiotic during short-term overseas travel (within 7 days) compared to placebo (time frame: Baseline (pre-travel) and post-travel (within 1 day after return)). 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 15 Jul 2026.