Correlation of Toxins With Gastrointestinal (GI) and Overall Health

NCT ID: NCT06278311

Last Updated: 2024-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-02-28

Study Completion Date

2026-01-31

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Patients

This group will include individuals presenting with digestive and/or non-digestive symptoms or conditions and whose medical evaluation necessitates 'toxin assessment.'

No interventions assigned to this group

Healthy controls

This group will include individuals not presenting with digestive and/or non-digestive symptoms or conditions and who volunteer to provide urine samples for 'toxin assessment.'

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Los Angeles Integrative Gastroenterology and Nutrition, Inc

UNKNOWN

Sponsor Role collaborator

Vibrant America Clinical Lab

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dr. Farshid S Rahbar, MD

Role: PRINCIPAL_INVESTIGATOR

Los Angeles Integrative Gastroenterology and Nutrition, Inc

Hari K Krishnamurthy, MS

Role: PRINCIPAL_INVESTIGATOR

Vibrant America Clinical Lab

Locations

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Los Angeles Integrative Gastroenterology and Nutrition, Inc

Los Angeles, California, United States

Site Status

Vibrant America Clinical Lab

Santa Clara, California, United States

Site Status

Countries

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United States

Central Contacts

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Hari K Krishnamurthy, MS

Role: CONTACT

866-364-0963

Dr. Farshid S Rahbar, MD

Role: CONTACT

310-289-8000

Facility Contacts

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Dr. Farshid S Rahbar, MD

Role: primary

310-289-8000

Hari K Krishnamurthy, MS

Role: primary

866-364-0963

Other Identifiers

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20235761

Identifier Type: -

Identifier Source: org_study_id

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