Correlation of Toxins With Gastrointestinal (GI) and Overall Health

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorVibrant America Clinical Lab

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Patients suffering from gastrointestinal and/or other symptoms

Patients willing to provide urine samples

Patients willing to provide consent

Disqualifiers

Use of antibiotics 2 weeks prior to the study

Patients unwilling to consent

Trial 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.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: Patients
Group B: Healthy controls

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year
2

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.'

Time frame
1 year
3

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.

Time frame
1 year

Secondary outcomes

1

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.

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vibrant America Clinical Lab

Lead sponsor

Los Angeles Integrative Gastroenterology and Nutrition, Inc

Collaborator

This trial is not recruiting at the moment. You can still explore other options: