Correlation of Toxins With Gastrointestinal (GI) and Overall Health
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Gastrointestinal Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Association of Presenting Symptoms and Diagnosis, With Urinary Mycotoxins, Metals, Polyfluorinated Alkyl Substance (PFAS) and Environmental Toxins - A Prospective Study in an Urban Gastroenterology Practice
Overview
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.
Detailed description
This study aims to use urine samples to understand the effect of toxins such as environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health. Urine samples will be tested using mass-spectroscopy-based techniques. A 'total toxicity score' will be calculated based on the urine analysis of toxins. A 'symptoms score' will be determined using the 'Symptom History' form which will be used to assess the patient's GI conditions. Additionally, a 'diagnosis score' will be calculated from the diagnosis generated in the electronic medical record (EMR). The determined 'total toxicity score' will be correlated with the 'symptoms score' and the 'diagnosis score.' The observations from this study will help us understand the potential effect of environmental toxins, heavy metals, PFAS and mycotoxins on GI and overall health.
Primary outcome measures
- Determination of the Total Toxicity score [Time frame: 1 year]
- Determination of the Symptom score [Time frame: 1 year]
- Determination of the Diagnosis score [Time frame: 1 year]
Secondary outcome measures (1)
- Determination of individual scores [Time frame: 1 year]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Los Angeles Integrative Gastroenterology and Nutrition, Inc — Los Angeles
- Vibrant America Clinical Lab — Santa Clara
Identifiers
NCT: NCT06278311 · 20235761