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NCT Number: NCT06278311

Correlation of Toxins With Gastrointestinal (GI) and Overall Health

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Los Angeles Integrative Gastroenterology and Nutrition, Inc, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Determination of the Total Toxicity score

    Time frame: 1 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.

  2. Determination of the Symptom score

    Time frame: 1 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.'

  3. Determination of the Diagnosis score

    Time frame: 1 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.

Secondary outcomes

  1. Determination of individual scores

    Time frame: 1 year

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Farshid S Rahbar, MD

CONTACT

[email protected]

310-289-8000

Hari K Krishnamurthy, MS

CONTACT

[email protected]

866-364-0963

Sponsors and collaborators

Lead sponsor

Vibrant America Clinical Lab

Industry

Collaborators

  • Los Angeles Integrative Gastroenterology and Nutrition, Inc

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 26, 2024
Registry last updated
Nov 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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