Health Condition 1: K30- Functional dyspepsia
Conditions
Interventions
Intervention1: Proton Pump Inhibitor(PPI) Group: will receive PPI based H Pylori eradication regime in the form of 14 days of clarithromycin 500 mg twice a day, amoxicillin 1000 mg twice a day, and Es
Sponsors
Dr Sanjib Kumar Kar
Eligibility
Inclusion criteria
Inclusion criteria: Consecutive adult ( more than and equal to 18 years age) patients with Functional Dyspepsia(ROME IV criteria) with H. pylori positive by either Rapid urease test or Urea breath test will be included in the study.
Exclusion criteria
Exclusion criteria: 1. Pregnant and lactating females 2. Children and adolescents (age lessthan18 years ) 3. Those with predominant symptoms of heartburn, irritable bowel syndrome, history of peptic ulcer, upper gastrointestinal (GI) tract surgery, biliary colic and allergies to study medication 4. Those with esophagitis, peptic ulcer, polyp, or mass lesion 5. Those who have received previous eradication therapy for H. pylori 6. Those who have received antibiotics or bismuth during last 4 weeks prior to enrolment, proton pump inhibitors (PPI) or Potassium Competitive Acid Blocker(PCAB) in last 2 weeks prior to enrolment, or histamine-2 receptor blockers 1 week prior to enrolment 7. Those on drugs which have interactions with anti-H. pylori drugs 8. Those unable to answer the study questionnaires 9. Those with uncontrolled diabetes mellitus (HbA1c more than 9 ) and uncontrolled thyroid status (thyroid-stimulating hormone (TSH) more than 10 mIU per litre or less than 0.5mIU per litre) 10. Those not willing to give written consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of treatment success rate between Proton Pump Inhibitor group, Potassium Competitive Acid Blocker group and Standard Medical Treatment group. Treatment success is defined as absence of symptoms or minimal symptoms with reduction of Short Form Leeds Dyspepsia Questionnaire score by at least four to five points from the total score or at least thirty percent reduction from baseline.Timepoint: Eight weeks after completion of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of Helicobacter pylori eradication rate between Proton Pump Inhibitor based regimen group and Potassium Competitive Acid Blocker based regimen group. Eradication is defined as negative rapid urease test or negative urea breath test.Timepoint: Two weeks after completion of treatment. | — |
Countries
India
Contacts
Public ContactDr Sanjib Kumar Kar
Indian Institute of Gastroenterology and Hepatology
Outcome results
None listed