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Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns

20 września 2026 zaktualizowane przez: Mohan Ramchandani, Asian Institute of Gastroenterology, India

Determinants of Helicobacter Pylori Infection: Role of Dietary and Lifestyle Patterns - Cross Sectional Study

This cross-sectional observational study aims to determine the prevalence of Helicobacter pylori (H. pylori) infection among Information Technology (IT) professionals working in Hyderabad, India, and to identify dietary, lifestyle, occupational, and clinical factors associated with infection. H. pylori is a common bacterial infection of the stomach and is an important cause of chronic gastritis, peptic ulcer disease, and gastric cancer.

Approximately 1,000 eligible IT professionals will be enrolled from participating IT companies using stratified random sampling. Participants will complete a structured questionnaire covering demographic characteristics, dietary habits, occupational factors, gastrointestinal symptoms, lifestyle factors, medical history, and recent medication use. Active H. pylori infection will be determined using the carbon-14 (C14) urea breath test performed at the workplace under standardized conditions.

The study will estimate the prevalence of H. pylori infection in this occupational group and evaluate whether factors such as outside food consumption, office-delivered meals, restaurant dining, street food intake, work schedules, and lifestyle habits are associated with infection. The findings may help identify modifiable risk factors and contribute to the development of workplace health promotion and preventive strategies for IT professionals.

Przegląd badań

Status

Jeszcze nie rekrutacja

Szczegółowy opis

Helicobacter pylori (H. pylori) is a spiral-shaped, gram-negative bacterium that colonizes the gastric mucosa and is one of the most common chronic bacterial infections worldwide. It is recognized by the World Health Organization as a Group I carcinogen because of its established association with gastric adenocarcinoma. Persistent infection is also associated with chronic gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma, and dyspeptic symptoms.

Although the prevalence of H. pylori infection has declined in many countries, it remains an important public health problem in India, where prevalence varies considerably across different regions and populations. Transmission is influenced by environmental, socioeconomic, sanitation, and dietary factors. Recent evidence suggests that occupational lifestyle and eating behaviors may also influence infection risk.

Information Technology (IT) professionals represent a unique occupational group characterized by prolonged working hours, sedentary work, irregular meal timings, frequent reliance on restaurant food, office-delivered meals, food delivery services, and high workplace stress. Despite the large and rapidly growing IT workforce in India, there is limited information regarding the prevalence of H. pylori infection and its associated risk factors in this population.

Typ studiów

Obserwacyjny

Zapisy (Szacowany)

1000

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat do 55 lat (Dorosły)

Akceptuje zdrowych ochotników

Tak

Płeć kwalifikująca się do nauki

Wszystko

Metoda próbkowania

Próbka prawdopodobieństwa

Badana populacja

The study population will include approximately 1,000 adult Information Technology (IT) professionals employed in participating IT companies in Hyderabad, Telangana, India. Eligible participants will be individuals aged 21 years or older who have been employed in their current organization for at least 6 months and provide written informed consent. The study will evaluate the prevalence of active Helicobacter pylori infection using the C14 urea breath test and assess its association with dietary patterns, lifestyle factors, occupational characteristics, clinical history, and medication use

Opis

Inclusion Criteria:

  1. Age ≥21 years.
  2. Currently employed as an Information Technology (IT) professional at a participating company in Hyderabad, India.
  3. Minimum 6 months of employment in the current organization.
  4. Willing to provide written informed consent for participation.
  5. Able to understand and complete the study questionnaire.
  6. Able to comply with fasting requirements (minimum 6 hours) before the C14 urea breath test.

Exclusion Criteria:

  1. Previous Helicobacter pylori eradication treatment.
  2. Use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (PCABs) within 2 weeks before testing.
  3. Use of antibiotics within 4 weeks before testing.
  4. Use of bismuth-containing compounds within 4 weeks before testing.
  5. History of gastric surgery.
  6. Current pregnancy or lactation.
  7. Active gastrointestinal bleeding.
  8. Known gastric malignancy.
  9. Inability to provide informed consent.
  10. Any condition that prevents completion of study procedures.

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Modele obserwacyjne: OTHER
  • Perspektywy czasowe: PROSPECTIVE

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Prevalence of active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Prevalence of active Helicobacter pylori infection among IT professionals, determined using the carbon-14 (C14) urea breath test. Infection status will be classified as positive or negative according to the manufacturer's recommended cut-off values.

Unit of Measure: Percentage (%) of participants with active H. pylori infection.

Measurement Tool: C14 urea breath test.

At the study visit during the 2-month data collection period

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Association between age and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period.

Association between participant age, measured in years, and active H. pylori infection status determined using the C14 urea breath test. Age will be assessed using the structured demographic questionnaire.

At the study visit during the 2-month data collection period.
Association between sex and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between participant sex, recorded as a categorical variable, and active H. pylori infection status determined using the C14 urea breath test. Sex will be recorded using the structured demographic questionnaire.

At the study visit during the 2-month data collection period
Association between marital status and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between marital status, recorded as a categorical variable, and active H. pylori infection status determined using the C14 urea breath test. Marital status will be assessed using the structured demographic questionnaire

At the study visit during the 2-month data collection period
Association between daily working hours and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between average daily working hours, measured in hours per day, and active H. pylori infection status determined using the C14 urea breath test. Daily working hours will be assessed using the structured occupational questionnaire

At the study visit during the 2-month data collection period
Association between frequency of outside-food consumption and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between frequency of outside-food consumption, measured in times per week, and active H. pylori infection status determined using the C14 urea breath test. Outside-food consumption will be assessed using the structured dietary questionnaire.

At the study visit during the 2-month data collection period
Association between office-tiffin consumption and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between office-tiffin consumption, recorded as yes/no, and active H. pylori infection status determined using the C14 urea breath test. Frequency of office-tiffin consumption will additionally be recorded in times per week using the structured dietary questionnaire

At the study visit during the 2-month data collection period
Association between smoking status and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between smoking status, categorized as never, former, or current smoker, and active H. pylori infection status determined using the C14 urea breath test. Smoking status will be assessed using the structured lifestyle questionnaire

At the study visit during the 2-month data collection period
Association between alcohol consumption and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between alcohol consumption frequency, measured in times per week, and active H. pylori infection status determined using the C14 urea breath test. Alcohol consumption will be assessed using the structured lifestyle questionnaire

At the study visit during the 2-month data collection period
Association between caffeine consumption and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between caffeine consumption, measured in cups per day, and active H. pylori infection status determined using the structured lifestyle questionnaire, and active H. pylori infection status determined using the C14 urea breath test.

At the study visit during the 2-month data collection period
Association between gastrointestinal symptoms and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period

Association between the presence or absence of gastrointestinal symptoms, including dyspepsia, epigastric pain, fullness, heartburn, nausea, and bloating, and active H. pylori infection status determined using the C14 urea breath test. Gastrointestinal symptoms will be assessed using the structured clinical questionnaire.

At the study visit during the 2-month data collection period
Association between recent medication use and active Helicobacter pylori infection
Ramy czasowe: At the study visit during the 2-month data collection period; medication use assessed during the preceding 4 weeks

Association between use of proton pump inhibitors, potassium-competitive acid blockers, NSAIDs, antibiotics, and probiotics during the preceding 4 weeks and active H. pylori infection status determined using the C14 urea breath test. Medication use will be assessed using the structured medication history questionnaire

At the study visit during the 2-month data collection period; medication use assessed during the preceding 4 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Publikacje i pomocne linki

Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Szacowany)

20 września 2026

Zakończenie podstawowe (Szacowany)

20 września 2027

Ukończenie studiów (Szacowany)

25 września 2027

Daty rejestracji na studia

Pierwszy przesłany

11 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 września 2026

Pierwszy wysłany (Rzeczywisty)

23 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

23 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2026

Ostatnia weryfikacja

1 czerwca 2026

Więcej informacji

Terminy związane z tym badaniem

Inne numery identyfikacyjne badania

  • DINE-IN HP Study

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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