Correlation of Toxins With Gastrointestinal (GI) and Overall Health
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
1 other identifier
observational
250
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2025
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2024
CompletedFirst Posted
Study publicly available on registry
February 26, 2024
CompletedStudy Start
First participant enrolled
February 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedNovember 19, 2024
November 1, 2024
11 months
February 15, 2024
November 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (1)
Determination of individual scores
1 year
Study Arms (2)
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.'
Eligibility Criteria
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.
You may qualify if:
- Patients suffering from gastrointestinal and/or other symptoms
- Patients willing to provide urine samples
- Patients willing to provide consent
You may not qualify if:
- Use of antibiotics 2 weeks prior to the study
- Patients unwilling to consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Los Angeles Integrative Gastroenterology and Nutrition, Inc
Los Angeles, California, 90067, United States
Vibrant America Clinical Lab
Santa Clara, California, 95054, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Farshid S Rahbar, MD
Los Angeles Integrative Gastroenterology and Nutrition, Inc
- PRINCIPAL INVESTIGATOR
Hari K Krishnamurthy, MS
Vibrant America Clinical Lab
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2024
First Posted
February 26, 2024
Study Start
February 1, 2025
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
November 19, 2024
Record last verified: 2024-11
Data Sharing
- IPD Sharing
- Will not share