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临床试验/NCT07837401
NCT07837401尚未招募不适用

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

Asian Institute of Gastroenterology, India0 个研究点目标入组 1,000 人开始时间: 2026年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,000
主要终点
Prevalence of active Helicobacter pylori infection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
21 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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.

排除标准

  • •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.

结局指标

主要结局

Prevalence of active Helicobacter pylori infection

时间窗: 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.

次要结局

  • Association between age and active Helicobacter pylori infection(At the study visit during the 2-month data collection period.)
  • Association between sex and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between marital status and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between daily working hours and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • 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 office-tiffin consumption and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between smoking status and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between alcohol consumption and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between caffeine consumption and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • Association between gastrointestinal symptoms and active Helicobacter pylori infection(At the study visit during the 2-month data collection period)
  • 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)

研究者

发起方
Asian Institute of Gastroenterology, India
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohan Ramchandani

MD, DM , FJGES , Director interventional Endoscopy , Senior Consultant Gastroenterologist

Asian Institute of Gastroenterology, India

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