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A Probiotic for Health Outcomes in Short-Term Overseas Travel

10 juli 2026 bijgewerkt door: DiproBio (Shanghai) Co., Ltd.

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.

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.

Studie Overzicht

Studietype

Ingrijpend

Inschrijving (Geschat)

40

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Beschrijving

Inclusion Criteria:

  1. Age: 18-65 years, inclusive, with no restriction on gender.
  2. Planned short-term round-trip travel from China to an overseas destination, with a total travel duration of no more than 7 days.
  3. Volunteers must be able to understand and comply with the study protocol, and provide written informed consent prior to initiation of any study procedures.

Exclusion Criteria:

  1. 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.
  2. Use of probiotic preparations, antibiotics, hormones, immunosuppressants, biological agents, or JAK inhibitors within 4 weeks prior to enrollment.
  3. Subjects with confirmed or uncontrolled parasitic infections.
  4. 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.
  5. 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.
  6. Participation in other clinical intervention studies involving drugs, dietary supplements, probiotics, or prebiotics within the past 4 weeks.
  7. 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.
  8. Known allergy to any components of the probiotic product.
  9. Subjects deemed unsuitable for participation in this clinical study by the investigator for any other reason.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Preventie
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verviervoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Placebo-vergelijker: Placebo-controlegroep
The intervention period begins on the day of travel departure. The placebo group receives an equal amount of carrier without live bacteria.
Experimenteel: Probiotic Intervention Group
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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Changes in gut microbiota in healthy Chinese adults taking probiotic during short-term overseas travel (within 7 days) compared to placebo
Tijdsspanne: Baseline (pre-travel) and post-travel (within 1 day after return)
Baseline (pre-travel) and post-travel (within 1 day after return)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

30 juli 2026

Primaire voltooiing (Geschat)

28 februari 2027

Studie voltooiing (Geschat)

31 maart 2027

Studieregistratiedata

Eerst ingediend

10 juli 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juli 2026

Eerst geplaatst (Werkelijk)

15 juli 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

15 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • THU-01-2026-0068

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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