Using biomarker-guided dietary supplements to improve quality of life in chronic pain patients
Pilot Study: Impact of Biomarker-Guided Dietary Supplementation on Quality-of-Life Measures in Subjects With Chronic Pain
This study is testing whether personalized dietary supplements based on specific urine tests can help improve the quality of life for people living with chronic pain.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Ethos Research & Development Industry-sponsored |
| Locations | 1 site (Newport, Kentucky) |
| Trial ID | NCT06247813 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the impact of dietary supplementation tailored to individual urinary biomarkers on the quality of life of patients suffering from chronic pain. Participants will receive one of three nutritional supplement formulas based on their specific urinary biomarker test results, targeting oxidative stress, inflammation, and nerve health. Over a 3-month period, the study will assess changes in urinary biomarker levels and quality of life measures related to pain. The goal is to establish a personalized treatment approach for chronic pain management.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing chronic pain for at least 3 months who have previously submitted a urinary biomarker sample.
Not a fit: Patients with recent infections, severe psychiatric disorders, a history of cancer, or dietary restrictions that conflict with the study supplements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective, individualized treatment plans for chronic pain patients, potentially improving their quality of life.
How similar studies have performed: While the approach of using biomarker-guided supplementation is innovative, similar studies have shown promise in personalized medicine, though this specific methodology is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Previously submitted a urinary biomarker sample and agreed to be contacted for research. * Be seeking treatment for chronic pain as defined as symptoms persisting for ≥ 3 months. * Be able to take oral medication and/or be willing to adhere to the supplement regimen. Exclusion Criteria: * Diagnosis of bacterial or viral infection during or 3 months prior to the study. * Severe or untreated psychiatric disturbance and/or any psychiatric disorder that required hospitalization in the year prior to the screening visit. * A history of cancer within 5 years prior to screening visit. * Be pregnant or breast-feeding or have plans to become pregnant at any time during the study * Participant has a known sensitivity or allergy to any of the ingredients in the study products. * Participant has any dietary restriction that prevents the participant from consuming any of the ingredients in the study products.
Where this trial is running
Newport, Kentucky
- Ethos Research and Development — Newport, Kentucky, United States (Recruiting)
Study contacts
- Principal investigator: Joshua Gunn, PhD — Ethos Research and Development
- Study coordinator: Brianna Krause, MS
- Email: brianna.krause@ethosrd.com
- Phone: (513) 400-3057
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.