Naturopathic Approaches to Ulcerative Colitis

NCT07521904 | Not Yet Recruiting

• 1 other identifier: JG012926
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Ulcerative Colitis

Keywords

naturopathy; naturopathic medicine; UC; ulcerative colitis; IBD; inflammatory bowel disease

Outcome Measures

Primary Outcomes (2)

• Patient-Modified Simple Clinical Colitis Activity Index

  There are over 30 patient reported outcomes (PRO) instruments in use for patients with IBD.14 The oldest and most widely used is the Patient-Modified Simple Clinical Colitis Activity Index \[P-SCCAI\], a validated, non-proprietary patient-reported outcome measure for ulcerative colitis. The P-SCCAI is a patient-worded version of the Simple Clinical Colitis Activity Index and includes six symptom domains: stool frequency (day and night), urgency, rectal bleeding, general well-being, and extra-intestinal manifestations. Total scores range from 0-19, with ≥5 commonly used to define active disease.

  6 months

• Health Status

  PROMIS-29 The Patient Reported Outcomes Measurement Information System (PROMIS) provides a standardized, reliable, and valid measure of health status. The profile is a collection of self-report short forms containing items from seven PROMIS domains (Physical Function, Anxiety, Depression, Fatigue, Sleep Disturbance, Ability to Participate in Social Roles and Activities, Pain Interference, and Pain Intensity). The PROMIS-29 Profile consists of four questions per domain rated on a 5-point rating scale along with a 1 question Pain Intensity section rated on an 11-point scale. A raw score ranges from 29 to 150, and can be converted into T-scores which are referenced to mean score levels in the general U.S. population. Lower PROMIS scores have been shown to predict reduced health related quality of life for multiple chronic conditions. We will measure average change in each participant's PROMIS - 29 score from week zero to week twelve and twenty four.

  6 months

Secondary Outcomes (5)

• CARE

  6 months

• Patient empowerment

  6 months

• The Patient-Centered Care-Perceived Provider Support-Empowerment Scale

  6 months

• Treatment characteristics

  6 months

• Adverse Events

  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 UC as the primary cause of their visit.

You may qualify if:

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

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

Location

MeSH Terms

Conditions

Colitis, Ulcerative; Inflammatory Bowel Diseases

Interventions

Naturopathy

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Central Study Contacts

Joshua Goldenberg, ND

CONTACT

2068830119; jgoldenberg@nunm.edu

Mark Davis, ND

CONTACT

markdavisnd@gmail.com

Study Design

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

Study Record Dates

• First Submitted: March 28, 2026
• First Posted: April 13, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

US (1)