Recruiting

Naturopathic Approaches

Sponsor:

National University of Natural Medicine

Code:

NCT06721624

Conditions

Irritable Bowel Syndrome (IBS)

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Naturopathic medicine

Study Details

Brief 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.

Conditions

Irritable Bowel Syndrome (IBS)

Study ID

NCT06721624

Start date

Nov 1, 2024

Status verified date

Dec, 2024

Completion date

Nov, 2025

Anticipated

Primary completion date

Nov, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

\*Inability to read and write in English.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Naturopathic medicine

Whole system naturopathic medicine

Primary outcome measure

  • IBS Severity [ Time Frame: 6 months ]
  • Health Status [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Joshua Goldenberg, ND

2068830119jgoldenberg@nunm.edu

Locations

Helfgott Research Institute - National University of Natural Medicine

Recruiting

Portland, Oregon, United States, 97201

More Information

Sponsor

National University of Natural Medicine

Last update posted

Dec 6, 2024

Last verified

Dec, 2024

Keywords

  • Irritable Bowel Syndrome
  • IBS
  • naturopathy
  • naturopathic medicine

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National University of Natural Medicine on 2024-12-06.