Prospective Observational Study of Naturopathic Approaches to IBS

NCT06721624 | Recruiting

• 1 other identifier: RB82224
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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)

Keywords

Irritable Bowel Syndrome; IBS; naturopathy; naturopathic medicine

Outcome Measures

Primary Outcomes (2)

• IBS Severity

  IBS-SSS

  6 months

• Health Status

  PROMIS-29

  6 months

Secondary Outcomes (6)

• 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

Interventions

Naturopathic medicine OTHER

Whole system naturopathic medicine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants are adults (≥18 years of age) who present to the clinical co-investigators' practices with a pre-existing IBS diagnosis (or IBS-like gastrointestinal symptoms which lead to clinical personnel making a diagnosis of IBS via Rome IV criteria) as the primary cause of their visit.

You may qualify if:

• 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.

You may not qualify if:

• \*Inability to read and write in English.

Sponsors & Collaborators

• National University of Natural Medicine: lead
• Gastroenterology Association of Naturopathic Physicians: collaborator

Study Sites (1)

Helfgott Research Institute - National University of Natural Medicine

Portland, Oregon, 97201, United States

RECRUITING

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

Naturopathy

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Joshua Goldenberg, ND

CONTACT

2068830119; jgoldenberg@nunm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2024
• First Posted: December 6, 2024
• Study Start: November 1, 2024
• Primary Completion: November 1, 2025
• Study Completion: November 1, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Locations

US (1)