Elimination Diet for Food Sensitivities

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Food SensitivitiesElimination Diet - Behavioral
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing whether an 'elimination diet' can help identify food sensitivities in patients and improve their symptoms.

Eligible Conditions
  • Food Sensitivities

Treatment Effectiveness

Study Objectives

2 Primary · 3 Secondary · Reporting Duration: Baseline; Week 1; Week 2; Week 3; Week 4

Baseline - 4 weeks
Improvement in blood biomarker profile
Week 4
Food Sensitivity - Adequate Relief (FS-AR)
Improvement in severity of food sensitivity symptoms
Baseline; Week 4
Food Sensitivity - Quality of Life Questionnaire (FS-QoL)
Week 4
Food sensitivity - Global Improvement Scale (FS-GIS)

Trial Safety

Trial Design

1 Treatment Group

Elimination Diet
1 of 1

Experimental Treatment

220 Total Participants · 1 Treatment Group

Primary Treatment: Elimination Diet · No Placebo Group · N/A

Elimination Diet
Behavioral
Experimental Group · 1 Intervention: Elimination Diet · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Elimination Diet
2009
Completed Phase 2
~170

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline; week 1; week 2; week 3; week 4

Who is running the clinical trial?

Vibrant America Clinical LabLead Sponsor
Hari K Krishnamurthy, M.S.Principal InvestigatorPI

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are aged between 18 and 65 years.
You have IgG and/or IgA-mediated food reactions leading to food sensitivity.