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临床试验/NCT07611162
NCT07611162尚未招募4 期

Comparative Effectiveness of Alginate, Magaldrate, Sucralfate, Proton Pump Inhibitors, and Diet in Laryngopharyngeal Reflux Disease

University of Mons1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年5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
800
试验地点
1

研究概览

简要总结

The goal of this randomized controlled trial is to compare the effectiveness of different treatments for laryngopharyngeal reflux disease (LPRD) in adult patients with confirmed symptoms and signs of the condition. The main question it aims to answer is:

Which treatment (Proton Pump Inhibitors (PPIs), alginate, magaldrate, sucralfate, or diet) leads to the greatest improvement in LPRD symptoms and clinical signs over 3 months? Researchers will compare proton pump inhibitors to alternative medical treatments and dietary management to see which approach is most effective and better tolerated.

Participants will:

  • undergo a clinical ENT examination with scoring of reflux signs (RSA)
  • complete symptom questionnaires (RSS) assessing severity, frequency, and impact of symptoms
  • receive one of the study treatments (medication or dietary intervention)
  • be evaluated at baseline and again after 3 months of treatment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive 24-h HEMII-pH > 1 event

排除标准

  • Smoker (>5 cigarettes/day) , alcohol dependence (>3 units/day),
  • upper respiratory tract infection within the last month,
  • pregnancy,
  • neurological or psychiatric illness,
  • previous history of neck surgery or trauma,
  • malignancy,
  • history of head and neck radiotherapy
  • active seasonal allergies or asthma.

研究者

发起方
University of Mons
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jerome lechien

Chairman & Professor of General Surgery

University of Mons

研究点 (1)

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