Determinants of Helicobacter Pylori Infection: Role of Dietary and Lifestyle Patterns - Cross Sectional Study
| Registry | NCT07837401 |
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| Status | Not yet recruiting |
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| Study type | Observational |
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| Enrollment | 1000 (Estimated) |
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| Sponsor | Asian Institute of Gastroenterology, India (Other) |
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| Conditions | Helicobacter Pylori Infection |
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| Dates | start 2026-09-20 (estimated), primary completion 2027-09-20 (estimated), completion 2027-09-25 (estimated), first posted 2026-09-23, last updated 2026-09-23 |
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All trials for Helicobacter Pylori Infection
-Summary
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.
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+Detailed description
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.
+Outcome measures
Primary outcomes
- Prevalence of active Helicobacter pylori infection [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.
Secondary outcomes
- Association between age and active Helicobacter pylori infection [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.
- Association between sex and active Helicobacter pylori infection [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.
- Association between marital status and active Helicobacter pylori infection [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
- Association between daily working hours and active Helicobacter pylori infection [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
- Association between frequency of outside-food consumption and active Helicobacter pylori infection [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.
- Association between office-tiffin consumption and active Helicobacter pylori infection [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
- Association between smoking status and active Helicobacter pylori infection [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
- Association between alcohol consumption and active Helicobacter pylori infection [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
- Association between caffeine consumption and active Helicobacter pylori infection [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.
- Association between gastrointestinal symptoms and active Helicobacter pylori infection [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.
- Association between recent medication use and active Helicobacter pylori infection [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
+Eligibility
Sex: All, ages: 21 Years to 55 Years, accepts healthy volunteers
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.
+Publications
- Results publication: Leppanen J, Stone H, Lythgoe DJ, Williams S, Horvath B. Sailing in rough waters: Examining volatility of fMRI noise. Magn Reson Imaging. 2021 May;78:69-79. doi: 10.1016/j.mri.2021.02.009. Epub 2021 Feb 12. PMID 33588017