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临床试验/CTRI/2026/03/105993
CTRI/2026/03/105993尚未招募4 期

Role of Helicobacter pylori Eradication in Patients with Functional Dyspepsia Using Proton Pump Inhibitor and Potassium Competitive Acid Blocker Based Regimens in Eastern India: A Single Centre Randomized Controlled Trial

Dr Sanjib Kumar Kar1 个研究点 分布在 1 个国家目标入组 552 人开始时间: 2026年4月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
552
试验地点
1

研究概览

简要总结

Brief Summary (for Clinical Trials Registry of India CTRI):

Functional dyspepsia is common in India, affecting nearly thirty percent of adults. It is characterized by postprandial fullness, early satiation, epigastric pain, or epigastric burning without any identifiable organic cause on routine evaluation. The role of Helicobacter pylori infection in causing symptoms of functional dyspepsia remains controversial. Some studies and meta analyses have shown improvement in symptoms after eradication therapy, while others have shown little or no benefit. Because of these conflicting findings and limited data from India, the benefit of eradication therapy in patients with functional dyspepsia is still uncertain.

This study aims to evaluate whether eradication of Helicobacter pylori provides additional symptomatic benefit compared with standard medical treatment in patients with Helicobacter pylori positive functional dyspepsia. In this prospective randomized controlled trial, patients will receive either Proton Pump Inhibitor based eradication therapy, Potassium Competitive Acid Blocker based eradication therapy, or standard medical treatment. The study will compare improvement in dyspeptic symptoms and eradication rates among the treatment groups. The results may help clarify the role of Helicobacter pylori eradication in the management of functional dyspepsia in the Indian population.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • 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.

排除标准

  • Pregnant and lactating females
  • Children and adolescents (age lessthan18 years )
  • 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
  • Those with esophagitis, peptic ulcer, polyp, or mass lesion
  • 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
  • Those on drugs which have interactions with anti-H.
  • pylori drugs
  • 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)
  • Those not willing to give written consent.

研究者

发起方
Dr Sanjib Kumar Kar
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Sanjib Kumar Kar

Indian Institute of Gastroenterology and Hepatology

研究点 (1)

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