Clinical Trial

Prospective Observational Study of Naturopathic Approaches to IBS

Recruiting
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Record status
This record was last updated December 6, 2024 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
Summary
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.
Trial Details
NCT Number NCT06721624
Lead Sponsor National University of Natural Medicine
Collaborators: Gastroenterology Association of Naturopathic Physicians
Conditions Irritable Bowel Syndrome (IBS)
Enrollment 50 participants
Start Date 2024-11-01
Primary Completion 2025-11 (estimated)
Study Completion 2025-11 (estimated)
Updated on ClinicalTrials.gov 2024-12-06