Helicobacter Pylori InfectionNCT07837401
Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns
An observational study of Helicobacter Pylori Infection, run by Asian Institute of Gastroenterology, India.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection
- How many people
- 1,000 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2026to 25 Sep 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 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
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- Active gastrointestinal bleeding.
- Known gastric malignancy.
- Inability to provide informed consent.
- Any condition that prevents completion of study procedures.
About this study
Official title: 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.
Read the 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.
- Conditions
- Helicobacter Pylori Infection
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period
Secondary outcomes (11)
Association between age and active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period.
Association between sex and active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period
Association between marital status and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period
Association between daily working hours and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period
Association between frequency of outside-food consumption and active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period
Association between office-tiffin consumption and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period
Association between smoking status and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period
Association between alcohol consumption and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period
Association between caffeine consumption and active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period
Association between gastrointestinal symptoms and active Helicobacter pylori infection
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.
Measured: At the study visit during the 2-month data collection period
Association between recent medication use and active Helicobacter pylori infection
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
Measured: At the study visit during the 2-month data collection period; medication use assessed during the preceding 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start20 Sep 2026 (estimated)
- Primary completion20 Sep 2027 (estimated)
- Study completion25 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asian Institute of Gastroenterology, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohan Ramchandani, Asian Institute of Gastroenterology, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837401
- Sponsor's protocol ID
- DINE-IN HP Study
- Status last verified
- Jun 2026
- First submitted
- 11 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33588017