Assessment of Improvement in Food Sensitivity Related Symptoms on Employment of Personalized Elimination Diet
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 18
- 主要终点
- Improvement in severity of food sensitivity symptoms
研究概览
简要总结
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.
详细描述
After seeking appropriate consent, patients' blood samples will be tested for the reactivity toward 262 foods using peptide and protein microarrays. Food protein extraction will be carried out in different solvents such as water and alcohol. The peptide microarrays will synthesize the entire food proteins as peptides in situ while the protein microarrays will test for water-soluble and alcohol-soluble fractions. Thus, food sensitivity testing will be carried out at 3 different levels including water-soluble proteins, alcohol-soluble proteins, and peptides. Patients' blood samples can be tested at all 3 levels or a combination of these. This decision lies at the discretion of the physician.
Based on the test results and as per the physician's recommendations, a suitable elimination diet will be suggested to the patient. Personalized diet suggestions for each patient will be made by the physician. The patient will follow the diet for 4 weeks and blood samples will be tested again on completion of the diet, using peptides and protein microarrays. Additionally, based on the physician's recommendations, the time duration for which a patient follows the personalized elimination diet can be modified.
The patients will periodically have to fill out diagnostic questionnaires which will help assess the changes in their food sensitivity-related symptoms. Changes in the blood biomarkers and improvement in symptoms will be monitored during the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Improvement in severity of food sensitivity symptoms
时间窗: Baseline; Week 1; Week 2; Week 3; Week 4
Food Sensitivity - Symptom Severity Scale (FS - SSS) is a 16-item questionnaire that will assess the severity of the patient's food sensitivity-related symptoms. The scores range from 0 (none) to 5 (severe).
Improvement in blood biomarker profile
时间窗: Baseline - 4 weeks
The peptide and protein microarrays will be used to test patients' blood samples prior to and post-employment of the elimination diet, and changes in the blood biomarker profile will be monitored. Testing will be carried out at baseline and then after 4 weeks, on completion of the diet.
次要结局
- Food sensitivity - Global Improvement Scale (FS-GIS)(Week 4)
- Food Sensitivity - Quality of Life Questionnaire (FS-QoL)(Baseline; Week 4)
研究者
Hari Krishnamurthy
Director - Biomedical Engineering
Vibrant America Clinical Lab