Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns
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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
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
Kuvaus
Inclusion Criteria:
- Age ≥21 years.
- Currently employed as an Information Technology (IT) professional at a participating company in Hyderabad, India.
- Minimum 6 months of employment in the current organization.
- Willing to provide written informed consent for participation.
- Able to understand and complete the study questionnaire.
- Able to comply with fasting requirements (minimum 6 hours) before the C14 urea breath test.
Exclusion Criteria:
- Previous Helicobacter pylori eradication treatment.
- Use of proton pump inhibitors (PPIs) or potassium-competitive acid blockers (PCABs) within 2 weeks before testing.
- Use of antibiotics within 4 weeks before testing.
- Use of bismuth-containing compounds within 4 weeks before testing.
- History of gastric surgery.
- Current pregnancy or lactation.
- Active gastrointestinal bleeding.
- Known gastric malignancy.
- Inability to provide informed consent.
- Any condition that prevents completion of study procedures.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: OTHER
- Aikanäkymät: PROSPECTIVE
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Prevalence of active Helicobacter pylori infection
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Association between age and active Helicobacter pylori infection
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- DINE-IN HP Study
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .