Ulcerative Colitis
Conditions
Keywords
naturopathy, naturopathic medicine, UC, ulcerative colitis, IBD, inflammatory bowel disease
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.
Detailed description
Ulcerative colitis (UC) is a chronic inflammatory bowel disease (IBD) characterized by relapsing and remitting inflammation of the colonic mucosa. UC carries a significant burden in terms of quality of life, healthcare utilization, and long-term risk of colorectal cancer. While numerous pharmaceutical therapies exist-including aminosalicylates, corticosteroids, immunomodulators, biologics, and small molecules-many patients experience suboptimal response, adverse effects, or prefer to avoid long-term immunosuppression. As a result, many individuals with UC seek out complementary and alternative medicine, including naturopathic care. However, naturopathic approaches to UC are understudied. The investigators aim to describe naturopathic approaches to UC and to establish pilot data on before-and-after changes in validated UC 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 investigators will recruit adult patients diagnosed with ulcerative colitis who are under the care of naturopathic doctors. Participants' UC symptoms will be measured using a validated instrument, the Patient-Modified Simple Clinical Colitis Activity Index \[P-SCCAI\]. Adverse events and treatment descriptions will also be collected. 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 address substantial evidence gaps and to gather preliminary evidence to inform the design of a future randomized, controlled trial.
Interventions
Whole system naturopathic medicine
Sponsors
National University of Natural Medicine
Gastroenterology Association of Naturopathic Physicians
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
\*Adults (≥18 years of age) who have active UC (P-SCCAI \>4)
Exclusion criteria
\*Inability to read and write in English.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-Modified Simple Clinical Colitis Activity Index | 6 months | 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. |
| Health Status | 6 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| CARE | 6 months | The clinician's interpersonal practice will be assessed using the Consultation and Relational Empathy (CARE) Measure, a validated 10-item patient-reported instrument that evaluates practitioner empathy during the clinical encounter. Each item is scored from 1 to 5, yielding a total score range of 10 to 50, with higher scores indicating greater perceived clinician empathy. The CARE Measure has demonstrated validity and reliability in multiple health care settings and has also been used to assess interpersonal aspects of care in integrative medicine contexts. Outcome assessment will occur over 6 months. |
| Patient empowerment | 6 months | 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. Each item is scored on a Likert scale from 1 to 5, yielding a total score range of 5 to 25, with higher scores indicating greater patient empowerment. Outcome assessment will occur over 6 months. |
| The Patient-Centered Care-Perceived Provider Support-Empowerment Scale | 6 months | 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. Each component instrument will be scored according to its validated scoring system, with item responses rated on Likert scales (e.g., 1 to 4 or 1 to 5). For all included measures, higher scores indicate greater perceived patient-centeredness, provider support, and patient empowerment. Outcome assessment will occur over 6 months. |
| Treatment characteristics | 6 months | Prescribed treatments (e.g. diets, supplements, medications, lifestyle changes), including doses and frequencies with be extracted from chart notes. |
| Adverse Events | 6 months | 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. |
Countries
United States
Contacts
CONTACTJoshua Goldenberg, ND
CONTACTMark Davis, ND
Outcome results
None listed