CompletedNot Applicable

Effect of Personalized Elimination Diet on Food Sensitivity Related Symptoms

United States80 participantsStarted 2023-01-02

Plain-language summary

The goal is to identify food sensitivity in patients and assess whether the avoidance of the reaction-inducing foods via an 'elimination diet' leads to improvement in patient symptoms and overall well-being.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients aged between 18 to 65 years. * Patients suffering from food sensitivity symptoms * Patients having Immunoglobulin G (IgG) and Immunoglobulin A (IgA)-mediated food reactions leading to food sensitivity * Patients agreeing to follow the diet per testing * Patients willing to provide an informed consent Exclusion Criteria: * Patients suffering from chronic medical conditions like cancer * Pregnant subjects * Patients who have recently used antibiotics * Patients who have previously undergone treatments for food allergies/sensitivities * Patients who have been assigned an elimination diet before * Patients who are already following a restricted diet of any kind * Patients unwilling/unable to provide informed consent

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Improvement in blood biomarker profile

Timeframe: Baseline - 4 weeks

Improvement in severity of food sensitivity symptoms

Timeframe: Baseline; Week 1; Week 2; Week 3; Week 4

Trial details

NCT IDNCT05389683

SponsorVibrant America Clinical Lab

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2024-02-24

View on ClinicalTrials.gov More Food Sensitivity trials

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.