Correlation of Toxins With Gastrointestinal (GI) and Overall Health

Gastrointestinal Diseases Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06278311
• Other study ID #: 20235761
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: Vibrant America Clinical Lab
• Contact: Hari K Krishnamurthy, MS
• Phone: 866-364-0963
• Email: hari[@]vibrantsci.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 250
• Est. completion date: February 2025
• Est. primary completion date: February 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Digestive System Diseases
• Gastrointestinal Diseases

Locations

Country	Name	City	State
United States	Los Angeles Integrative Gastroenterology and Nutrition, Inc	Los Angeles	California
United States	Vibrant America Clinical Lab	Santa Clara	California

Sponsors (2)

Lead Sponsor	Collaborator
Vibrant America Clinical Lab	Los Angeles Integrative Gastroenterology and Nutrition, Inc

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.	1 year