Naturopathic Approaches to Ulcerative Colitis

Официальное название

Prospective Observational Study Of Naturopathic Approaches To IBS

Обзор

Ulcerative colitis (UC) is a long-term condition that causes inflammation in the large intestine. People with UC often have symptoms such as diarrhea, abdominal pain, and fatigue. These symptoms can come and go over time and can have a major impact on daily life. Although there are many medical treatments available, some patients do not respond well, experience side effects, or prefer to avoid long-term use of medications that affect the immune system. Because of this, many people with UC seek care from naturopathic doctors. This study aims to better understand how naturopathic care is used to treat UC and whether patients experience changes in their symptoms over time. In this study, adults with UC who are already receiving care from a naturopathic doctor will be followed for 12 weeks. The treatments will not be standardized; instead, each naturopathic doctor will provide individualized care based on their usual practice. Participants will complete a questionnaire that measures UC symptoms at the start of the study and again after 12 weeks. The study will compare symptom scores before and after treatment. Researchers will also collect information about the types of treatments used and any side effects or adverse events. This is an observational study, meaning there is no comparison group and no changes are made to participants' usual care. The goal is to gather early information about naturopathic care for UC and to help guide future, more rigorous studies.

Подробное описание

Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by relapsing and remitting inflammation of the colonic mucosa. UC carries a significant burden in terms of quality of life, healthcare utilization, and long-term risk of colorectal cancer. While numerous pharmaceutical therapies exist-including aminosalicylates, corticosteroids, immunomodulators, biologics, and small molecules-many patients experience suboptimal response, adverse effects, or prefer to avoid long-term immunosuppression. As a result, many individuals with UC seek out complementary and alternative medicine, including naturopathic care. However, naturopathic approaches to UC are understudied. The investigators aim to describe naturopathic approaches to UC and to establish pilot data on before-and-after changes in validated UC 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 investigators will recruit adult patients diagnosed with ulcerative colitis who are under the care of naturopathic doctors. Participants' UC symptoms will be measured using a validated instrument, the Patient-Modified Simple Clinical Colitis Activity Index \[P-SCCAI\]. Adverse events and treatment descriptions will also be collected. 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 address substantial evidence gaps and to gather preliminary evidence to inform the design of a future randomized, controlled trial.

Вмешательства

• Другое Naturopathic medicine
  Whole system naturopathic medicine

Первичные конечные точки

• Patient-Modified Simple Clinical Colitis Activity Index [Срок оценки: 6 months]
• Health Status [Срок оценки: 6 months]

Вторичные конечные точки (5)

• CARE [Срок оценки: 6 months]
• Patient empowerment [Срок оценки: 6 months]
• The Patient-Centered Care-Perceived Provider Support-Empowerment Scale [Срок оценки: 6 months]
• Treatment characteristics [Срок оценки: 6 months]
• Adverse Events [Срок оценки: 6 months]

Критерии участия

Критерии включения

\*Adults (≥18 years of age) who have active UC (P-SCCAI >4)

Критерии исключения

\*Inability to read and write in English.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Helfgott Research Institute - National University of Natural Medicine — Portland

Идентификаторы

NCT: NCT07521904 · JG012926

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗