Observational Study on Toxins and Gastrointestinal Health

This observational study aims to understand how different toxins, such as environmental toxins, heavy metals, PFAS (per- and polyfluoroalkyl substances), and mycotoxins, might affect your gastrointestinal (GI) and overall health. Researchers will analyze urine samples to measure these toxins and then compare those levels to your GI symptoms and medical diagnoses. The goal is to see if there's a connection between the amount of toxins in your body and your health. You may be able to join if you are 18 or older, have GI or other symptoms, and are willing to provide urine samples and consent. The study is looking to enroll 250 participants and is currently recruiting.

Study design
This is an observational study planning to enroll 250 participants. It will look at the correlation between toxin levels and health scores.
What's involved
You would need to provide urine samples and complete a 'Symptom History' form. This would occur over a 1-year period.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at 1 year for toxin levels, symptoms, and diagnoses.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06278311

Correlation of Toxins With Gastrointestinal (GI) and Overall Health

Not Yet Recruiting
Not specifiedAges 18+Observational
Vibrant America Clinical Lab
~250 participants
Updated 2024-11-19 on ClinicalTrials.gov

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determination of the Total Toxicity score
Measured over 1 year
+2 more outcomes measured
Gastrointestinal Diseases

NCT06278311

Where you'd take part

This study runs at 2 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Los Angeles Integrative Gastroenterology and Nutrition, Inc

    Los Angeles, Californiastudy coordinator listed

  • Vibrant America Clinical Lab

    Santa Clara, Californiastudy coordinator listed

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

  • Dr. Farshid S Rahbar, MD · PRINCIPAL_INVESTIGATOR · Los Angeles Integrative Gastroenterology and Nutrition, Inc
  • Hari K Krishnamurthy, MS · PRINCIPAL_INVESTIGATOR · Vibrant America Clinical Lab

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Eligibility criteria

Inclusion

Patients suffering from gastrointestinal and/or other symptoms
Patients willing to provide urine samples
Patients willing to provide consent

Exclusion

Use of antibiotics 2 weeks prior to the study
Patients unwilling to consent
  • Determination of the Total Toxicity score1 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.

  • Determination of the Symptom score1 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.'

  • Determination of the Diagnosis score1 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.