Prospective Observational Study of Naturopathic Approaches to IBS
ConditionIrritable Bowel Syndrome (IBS)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorNational University of Natural Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Naturopathic medicine
Other interventionWhole system naturopathic medicine
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
IBS Severity
IBS-SSS
Time frame
6 months2
Health Status
PROMIS-29
Time frame
6 monthsSecondary outcomes
1
Adequate Relief
IBS-AR
Time frame
6 months2
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 months3
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 months4
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 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
National University of Natural Medicine
Lead sponsor
Gastroenterology Association of Naturopathic Physicians
Collaborator
Source ClinicalTrials.gov