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Clinical Trials in the USA / NCT06278311
Starting soon Observational

Correlation of Toxins With Gastrointestinal (GI) and Overall Health

NCT06278311 · tracked via the Priya Life Science USA tracker
Sponsor
Vibrant America Clinical Lab
Phase
Observational
Started
2025-02
Last updated
2024-11-19

Condition(s) studied

Gastrointestinal Diseases

Study summary

The goal of this observational study is to evaluate the levels of urinary environmental toxins, heavy metals, PFAS and mycotoxins with gastrointestinal (GI) and overall health.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Patients suffering from gastrointestinal and/or other symptoms * Patients willing to provide urine samples * Patients willing to provide consent Exclusion Criteria: * Use of antibiotics 2 weeks prior to the study * Patients unwilling to consent

Primary outcome measure(s)

  • Determination of the Total Toxicity score — 1 year
    Mass spectroscopy-based techniques will be used to test participants' urine samples for environmental toxins, heavy metals, PFAS, and mycotoxins. A 'total toxicity score' will be calculated based on the results obtained from the urine analysis of these toxins. The range for total toxicity score lies between 0 (none) to 232 (severe). Higher scores correspond with worse outcomes.
  • Determination of the Symptom score — 1 year
    The Symptom History Form is a 90-item questionnaire that will assess participants' digestive and non-digestive symptoms. The scale ranges from 0 (absent) to 1 (present). This form will help determine the 'symptom score.'
  • Determination of the Diagnosis score — 1 year
    A diagnosis will be selected by the clinician as part of the medical evaluation during the follow-up patient visit. Diagnosis may be "confirmed," "suspected," or "rule out" all as part of a practitioner's clinical impressions. Each diagnosis score will be presented in the form of an International Classification of Diseases (ICD)-10 code. This will help determine the 'diagnosis score,' which applies only to the patient group.

Trial sites (2)

FacilityCityRegionStatus
Los Angeles Integrative Gastroenterology and Nutrition, Inc Los Angeles California
Vibrant America Clinical Lab Santa Clara California

Other trials for the same condition

First-in-human Study of IDRX-42 in Participants With Metastatic and/or Unresectable Gastrointestinal Stromal Tumors Active, not recruiting
An Observational Study of Patients With Chronic Gastrointestinal Disease Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06278311 on ClinicalTrials.gov ↗ ← All trials in the USA