Prospective Observational Study of Naturopathic Approaches to IBS

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.

Study Overview

• Status: Recruiting
• Conditions: Irritable Bowel Syndrome (IBS)
• Intervention / Treatment: Other: Naturopathic medicine

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Joshua Goldenberg, ND; Phone Number: 2068830119; Email: jgoldenberg@nunm.edu

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97201
      • Recruiting
      • Helfgott Research Institute - National University of Natural Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IBS Severity	IBS-SSS	6 months
Health Status	PROMIS-29	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adequate Relief	IBS-AR	6 months
CARE	The clinician's interpersonal practice will be described primarily through the CARE measure, a 10-item validated instrument designed to evaluate patient experiences of practitioner empathy. The CARE measure has demonstrated validity across a variety of health-care settings and its preliminary application in CIH settings suggests reliability in this setting	6 months
Patient empowerment	The 5-item Empowerment scale will be employed to evaluate the patient experiences of the clinical consultation with regards to the degree to which the practitioner encourages patient empowerment.	6 months
The Patient-Centered Care-Perceived Provider Support-Empowerment Scale	The Patient-Centered Care-Perceived Provider Support-Empowerment Scale is a trifecta of validated instruments developed to assess patients' perceptions of provider support, patient-centered care, and empowerment as they relate to health outcomes. These questionnaires aim at measuring the impact of the therapeutic relationship, the philosophy of healing, and CIH-specific techniques on treatment effects.	6 months
Diagnosis and treatment characteristics	The naturopathic diagnosis and treatment characteristics for each participant will also be extracted from patient charts. In particular, the naturopathic and differential diagnosis, and details of all prescribed treatments (e.g. diets, supplements, medications, lifestyle changes), including doses and frequencies.	6 months
Adverse Events	Total number of adverse events and serious adverse events (using NIH's Common Terminology Criteria for Adverse Events version 4.0). This will be measured by practitioner report using chart abstraction. Practitioners will be trained on grading and documenting adverse events, as well as using standardized AE forms, before subjects are enrolled.	6 months

Collaborators and Investigators

• Sponsor: National University of Natural Medicine
• Collaborators: Gastroenterology Association of Naturopathic Physicians

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2024
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): November 1, 2025

Study Registration Dates

• First Submitted: December 3, 2024
• First Submitted That Met QC Criteria: December 3, 2024
• First Posted (Estimated): December 6, 2024

Study Record Updates

• Last Update Posted (Estimated): December 6, 2024
• Last Update Submitted That Met QC Criteria: December 3, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Irritable Bowel Syndrome; IBS; naturopathy; naturopathic medicine
• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Colonic Diseases, Functional; Irritable Bowel Syndrome
• Other Study ID Numbers: RB82224

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No