Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Los Angeles Integrative Gastroenterology and Nutrition, Inc | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | This group will include individuals presenting with digestive and/or non-digestive symptoms or conditions and whose medical evaluation necessitates 'toxin assessment.' | ||
| Healthy controls | This group will include individuals not presenting with digestive and/or non-digestive symptoms or conditions and who volunteer to provide urine samples for 'toxin assessment.' |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year |
| 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.' | 1 year |
| 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hari K Krishnamurthy, MS | Contact | 866-364-0963 | hari@vibrantsci.com | |
| Dr. Farshid S Rahbar, MD | Contact | 310-289-8000 | Research@laintegrativegi.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Farshid S Rahbar, MD | Los Angeles Integrative Gastroenterology and Nutrition, Inc | Principal Investigator |
| Hari K Krishnamurthy, MS | Vibrant America Clinical Lab | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles Integrative Gastroenterology and Nutrition, Inc | Los Angeles | California | 90067 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| 1 year |
| Vibrant America Clinical Lab | Santa Clara | California | 95054 | United States |
|