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临床试验/NCT06721624
NCT06721624招募中不适用

Prospective Observational Study of Naturopathic Approaches to IBS

National University of Natural Medicine1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
1
主要终点
IBS Severity

研究概览

简要总结

Irritable bowel syndrome (IBS) is a common condition affecting about 4% of people worldwide and can significantly impact quality of life and healthcare costs. While there are medications available, few are consistently effective, leading many people with IBS to explore alternative treatments, including naturopathy. However, research on naturopathic approaches to IBS is limited.

This study aims to describe how naturopathy is used to treat IBS and to collect preliminary data on changes in IBS symptoms before and after treatment. It will use a prospective, observational design without a control group, focusing on outcomes from individualized naturopathic care provided by licensed practitioners.

Adult patients with diagnosed IBS or IBS-like symptoms will be recruited from naturopathic doctors affiliated with the Gastroenterology Association of Naturopathic Physicians. Participants' IBS symptoms will be assessed using validated tools (IBS-SSS and IBS-AR), and quality of life will be measured using the PROMIS-29 survey. Treatment details and any adverse effects will also be recorded. The main outcome will be the difference in symptoms and quality of life after 12 weeks of treatment. Results will be analyzed with statistical tests (p-value < 0.05) and summarized.

The findings from this pilot study will help fill knowledge gaps and provide a foundation for designing a more rigorous randomized controlled trial in the future.

详细描述

Irritable bowel syndrome (IBS) is a common functional bowel disorder with a worldwide prevalence of about 4% according to the Rome IV criteria. It has a significant impact on quality of life and societal expense. While there are pharmaceutical options available, few can be reliably recommended. Many IBS sufferers turn to complementary and alternative medicine, including naturopathy. Naturopathic approaches to IBS are poorly studied to date. The researchers aim to describe naturopathic approaches to IBS, as well as establish pilot data on before-and-after changes in validated IBS instruments. The study will employ a prospective, observational, naturalistic design. The uncontrolled before-and-after study will examine the outcomes associated with individualized, whole system naturopathic care as determined by each respective provider. The researchers will recruit adult patients either diagnosed with IBS or presenting with IBS-like symptoms, and presenting to the private practices of naturopathic doctors who are members of the Gastroenterology Association of Naturopathic Physicians. Participants' IBS symptoms will be measured using validated instruments (IBS-SSS and IBS-AR). Quality of life will be measured by the PROMIS - 29. Adverse events will be tracked, as will treatment descriptions. The primary outcomes will be before-and-after differences using week 12 as the primary endpoint. P-values will be set at 0.05 and descriptive and summary data will be presented. This study is designed to contribute to significant evidence gaps and to gather preliminary evidence to guide the design of a follow-up randomized, controlled trial.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Adults (≥18 years of age) who present with a pre-existing IBS diagnosis or IBS- like gastrointestinal symptoms.
  • Pre-existing IBS diagnosis or IBS-like gastrointestinal symptoms must be the primary cause of the visit.
  • An IBS diagnosis must be listed within the top 3 diagnoses for the visit and addressed in the individualized treatment plan.

排除标准

  • *Inability to read and write in English.

结局指标

主要结局

IBS Severity

时间窗: 6 months

IBS-SSS

Health Status

时间窗: 6 months

PROMIS-29

次要结局

  • Adequate Relief(6 months)
  • CARE(6 months)
  • Patient empowerment(6 months)
  • The Patient-Centered Care-Perceived Provider Support-Empowerment Scale(6 months)
  • Diagnosis and treatment characteristics(6 months)
  • Adverse Events(6 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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