Ulcerative ColitisNCT07521904
Naturopathic Approaches to Ulcerative Colitis
An observational study of Ulcerative Colitis, run by National University of Natural Medicine at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Naturopathic medicine
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adults (≥18 years of age) who have active UC (P-SCCAI >4)
Who cannot join
- Inability to read and write in English.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mark Davis, ND contact
United States1 site
Helfgott Research Institute - National University of Natural Medicine
Portland, Oregon, 97201
About this study
Official title: Prospective Observational Study Of Naturopathic Approaches To IBS
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.
Read more
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.
Read the 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.
- Conditions
- Ulcerative Colitis
- Being tested
- Naturopathic medicine
- Keywords
- naturopathy, naturopathic medicine, UC, ulcerative colitis, IBD, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naturopathic medicineOther
Whole system naturopathic medicine
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (5)
CARE
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.
Measured: 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. 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.
Measured: 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. 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.
Measured: 6 months
Treatment characteristics
Prescribed treatments (e.g. diets, supplements, medications, lifestyle changes), including doses and frequencies with be extracted from chart notes.
Measured: 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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Natural Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Gastroenterology Association of Naturopathic Physicians
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07521904
- Sponsor's protocol ID
- JG012926
- Status last verified
- Apr 2026
- First submitted
- 28 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study Of Naturopathic Approaches To IBS
- ClinicalTrials.gov ID
- NCT07521904
- Acronym / sponsor ID
- JG012926
- Conditions
- Ulcerative Colitis
- Keywords
- naturopathy, naturopathic medicine, UC, ulcerative colitis, IBD, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of Natural MedicineUniversity, hospital or other
- Collaborators
- Gastroenterology Association of Naturopathic Physicians
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adults (≥18 years of age) who have active UC (P-SCCAI >4)
Key exclusion criteria (1 listed)
- Inability to read and write in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naturopathic medicineWhole system naturopathic medicine | Other | – |
Primary outcome
Patient-Modified Simple Clinical Colitis Activity Index
Time frame: 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
Time frame: 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.
5 secondary outcomes
CARE
Time frame: 6 months
Patient empowerment
Time frame: 6 months
The Patient-Centered Care-Perceived Provider Support-Empowerment Scale
Time frame: 6 months
Treatment characteristics
Time frame: 6 months
Adverse Events
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Ulcerative Colitis
RecruitingPhase 4
A Study of Vedolizumab in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) in the Community Setting
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingPhase 1
A Study to Investigate the Safety and Tolerability of Multiple Study Interventions in Participants With Moderate to Severe Ulcerative Colitis
Colitis, Ulcerative
RecruitingPhase 2
A Study of AC-101 Tablets in Patients With Ulcerative Colitis
Ulcerative Colitis (UC)
Recruiting
Bacillus Probiotic Spores in Supporting the Treatment of Chronic Inflammatory Bowel Disease
Crohn Disease and Ulcerative Colitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mark Davis, ND contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by National University of Natural Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Goldenberg, ND (2068830119, jgoldenberg@nunm.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-Modified Simple Clinical Colitis Activity Index (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026; AzTrials last refreshed its copy on 29 Oct 2026.