Clinical trial NCT06278311: Correlation of Toxins With Gastrointestinal (GI) and Overall Health
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Gastrointestinal Diseases
Keywords: Gastrointestinal symptoms
Toxins
Environmental Toxins
Heavy metals
PFAS
Mycotoxins
Lead sponsor: Vibrant America Clinical Lab
Sponsor class: INDUSTRY
Collaborators: name: Los Angeles Integrative Gastroenterology and Nutrition, Inc
First posted: 2024-02-26
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

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

Primary outcomes:
measure: Determination of the Total Toxicity score
timeFrame: 1 year
measure: Determination of the Symptom score
timeFrame: 1 year
measure: Determination of the Diagnosis score
timeFrame: 1 year
Secondary outcomes:
measure: Determination of individual scores
timeFrame: 1 year
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Los Angeles Integrative Gastroenterology and Nutrition, Inc
state: California
city: Santa Clara
country: United States
facility: Vibrant America Clinical Lab
state: California
Study officials:
affiliation: Los Angeles Integrative Gastroenterology and Nutrition, Inc
name: Dr. Farshid S Rahbar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vibrant America Clinical Lab
name: Hari K Krishnamurthy, MS
role: PRINCIPAL_INVESTIGATOR
References: