Gastrointestinal Diseases
Conditions
Keywords
Gastrointestinal symptoms, Toxins, Environmental Toxins, Heavy metals, PFAS, Mycotoxins
Brief 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.
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.
Interventions
None listed
Sponsors
Los Angeles Integrative Gastroenterology and Nutrition, Inc
Vibrant America Clinical Lab
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determination of individual scores | 1 year | 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. |
Countries
United States
Contacts
Primary ContactHari K Krishnamurthy, MS
Backup ContactDr. Farshid S Rahbar, MD
Outcome results
None listed