Adding a Gastrointestinal Subscore to SOFA2 for Mortality Risk Assessment in the ICU: The SOFA2-GIS Study
NCT07586254
Critical Illness, Digestive System Diseases
Samsun, Atakum, Turkey (Türkiye)
View Trial DetailsNCT Number: NCT06278311
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Los Angeles Integrative Gastroenterology and Nutrition, Inc, Los Angeles, California, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.'
Time frame: 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.
Time frame: 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.
Contact information is provided by the study sponsor or research team.
Dr. Farshid S Rahbar, MD
CONTACT
Hari K Krishnamurthy, MS
CONTACT
Vibrant America Clinical Lab
Industry
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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