About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Patients suffering from gastrointestinal and/or other symptoms
Patients willing to provide urine samples
Patients willing to provide consent
Disqualifiers
Use of antibiotics 2 weeks prior to the study
Patients unwilling to consent
Trial population
The patient group will include individuals presenting with digestive and/or non-digestive symptoms or conditions and whose medical evaluation includes 'toxin assessment,' as determined by the treating physician.
Trial design
Case-control
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Determination of the Total Toxicity score
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
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
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.
Secondary outcomes
Determination of individual scores
Based on the urine analysis, individual scores for environmental toxins, heavy metals, PFAS, and mycotoxins will be determined. The individual score ranges are as follows: Environmental toxins: 0 (none) to 78 (severe); Heavy metals: 0 (none) to 40 (severe); PFAS: 0 (none) to 52 (severe); Mycotoxins: 0 (none) to 62 (severe). In all cases, higher scores correspond with worse outcomes.
Sponsors and contacts
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Vibrant America Clinical Lab
Lead sponsor
Los Angeles Integrative Gastroenterology and Nutrition, Inc
Collaborator
This trial is not recruiting at the moment. You can still explore other options: