ClinicalTrials.gg
Not yet recruitingNCT07837401Updated Sep 23, 2026

Factors Affecting Helicobacter Pylori Infection: Diet and Lifestyle Patterns

An observational study in Helicobacter Pylori Infection, sponsored by Asian Institute of Gastroenterology, India. Not yet recruiting. Open to participants aged 21 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-23.

Sponsored by Asian Institute of Gastroenterology, India · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
1,000
Ages
21 Years to 55 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Helicobacter Pylori Infection
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In context

Lead sponsor

Asian Institute of Gastroenterology, India is the lead sponsor of 135 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
21 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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 .
  9. Inability to provide .
  10. Any condition that prevents completion of study procedures.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: At the study visit during the 2-month data collection period

Secondary outcomes

  1. 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.

    Time frame: At the study visit during the 2-month data collection period.

  2. 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.

    Time frame: At the study visit during the 2-month data collection period

  3. 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

    Time frame: At the study visit during the 2-month data collection period

  4. 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

    Time frame: At the study visit during the 2-month data collection period

  5. 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.

    Time frame: At the study visit during the 2-month data collection period

  6. 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

    Time frame: At the study visit during the 2-month data collection period

  7. 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

    Time frame: At the study visit during the 2-month data collection period

  8. 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

    Time frame: At the study visit during the 2-month data collection period

  9. 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.

    Time frame: At the study visit during the 2-month data collection period

  10. 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.

    Time frame: At the study visit during the 2-month data collection period

  11. 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

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

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Study locations

No study locations are listed for this record.

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References and documents

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 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Sep 2026; primary completion for Sep 2027, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 11, 2026
First posted
Sep 23, 2026
StartEst.
Sep 20, 2026
Primary completionEst.
Sep 20, 2027
CompletionEst.
Sep 25, 2027
Last update
Sep 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 23, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07837401
Responsible party
Mohan Ramchandani (MD, DM , FJGES , Director interventional Endoscopy , Senior Consultant Gastroenterologist, Asian Institute of Gastroenterology, India) — Principal investigator
First posted
Sep 23, 2026
Start date
Sep 20, 2026 (estimated)
Primary completion
Sep 20, 2027 (estimated)
Completion
Sep 25, 2027 (estimated)
Last update
Sep 23, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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