An observational study in Irritable Bowel Syndrome (IBS), sponsored by National University of Natural Medicine. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-06.
Sponsored by National University of Natural Medicine · Observational
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.
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.
1,116 studies on the registry are indexed under Irritable Bowel Syndrome; 208 are open to participants now.
This study's planned enrollment of 50 is below the median of 160 across 191 observational studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →National University of Natural Medicine is the lead sponsor of 39 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
*Inability to read and write in English.
Whole system naturopathic medicine
IBS Severity
IBS-SSS
Time frame: 6 months
Health Status
PROMIS-29
Time frame: 6 months
Adequate Relief
IBS-AR
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6 months
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2024 (actual). Primary completion is estimated for Nov 2025, 12 months after the start.
Of 51 non-industry observational studies under Irritable Bowel Syndrome, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 193. This study's planned 12 months is below that.
Counting every sponsor, half of 65 studies reached it within 40 months; a quarter within 21 and three quarters within 109.
How these figures are worked out, and which studies are left out of them.
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