The Diagnostic Predictability of Food Allergy Testing in Individuals With Irritable Bowel Syndrome (IBS): A Comparison Between Various Laboratory Methods and an Elimination Diet. (The FAST Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Intra-individual agreement: food elimination challenge versus non-immunoglobulin E (IgE) mediated food allergy test results
研究概览
简要总结
Irritable bowel syndrome (IBS) sufferers often find that specific foods can exacerbate their symptoms; identifying which foods involves a long and arduous process. Different food allergy tests are marketed to IBS sufferers and healthcare practitioners as an easy way to identify these offending foods. Which test method might be best to use? This project compares the results of different food allergy methods versus an elimination/challenge diet to determine which method maybe superior in IBS sufferers.
详细描述
A variety of methods are available to assess food items that an individual with IBS may not tolerate well. No study has compared the predictability of each method to the results of an Elimination/Challenge (E/C) diet in individuals suffering from IBS and, or assessed which method might more accurately identify Non Immune Mediated Food Allergies (NIMFAs) in IBS suffers' An understanding of the relative agreement between these tests may help patients and practitioners make better decisions around how to best investigate NIMFAs for IBS and inform the design of larger studies on this topic.
The primary objective of this study is to determine the ability of each different laboratory method of food testing (IgG titres, Cytotoxic assay and electrodermal screening methods) for food reactivity to predict those foods that an individual with IBS reacts as assessed via an elimination diet in an adult population diagnosed with IBS by ROME III criteria and a score of greater than 200 on the IBS Severity Scoring System.
The secondary objective is determine inter-method agreement, at the individual level, between the sensitivity of food identified via each laboratory method, overall and according to severity of the reaction (high, medium, low, and no reaction).
The third objective is to measure the impact of the elimination of possible food allergies on the symptoms of IBS in the participants.
The fourth objective is to determine whether intestinal permeability maybe contributing to the symptomatology of IBS as assessed via an intestinal permeability test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female study participants aged 18-
- •A diagnosis of Irritable Bowel Syndrome as per ROME III criteria.
- •A classification of moderate to severe irritable bowel syndrome as indicated by the Irritable Bowel Severity Scoring System (score >200).
- •Not currently eliminating any foods from their diet.
- •Female study participants currently using an acceptable form of birth control who agree to maintain its use throughout the study (e.g. abstinence, oral contraceptives, barrier methods).
- •Ability to understand and sign the Informed Consent Form.
排除标准
- •Female study participants who are breastfeeding, pregnant, or are open to becoming pregnant in the next three months.
- •Study participants currently receiving medication for the treatment of IBS symptoms. Study participants currently receiving natural health products for treatment of IBS symptoms will be eligible for inclusion in the study is they agree to undergo a two-week washout period.
- •Those individuals with celiac disease.
- •Study participants currently experiencing nausea, fever, vomiting, bloody diarrhea, or severe abdominal pain.
- •Study participants with a previous diagnosis of Crohn's disease or ulcerative colitis by another health care provider.
- •Study participants who are immune-compromised (e.g. AIDS, lymphoma, patients undergoing long-term corticosteroid treatment).
- •Study participants who have recently (< 1 month) initiated dietary measures to control IBS symptoms.
- •Study participants with a history of major or complicated gastrointestinal surgery.
- •Study participants with severe endometriosis.
- •Study participants with malignant tumors or study participants undergoing chemotherapy or radiation therapy.
- •Study participants with known anaphylaxis reactions to specific consumed food items.
研究组 & 干预措施
Elimination/Challenge Diet
Once non-IgE mediated food allergy testing has been administered, study participants will follow food choices according to a pre-specified elimination diet for three weeks (Elimination phase). After the Elimination phase, study participants will introduce one food every three days (Challenge phase)and monitor their symptoms. Eight different foods will be introduced in the Challenge phase of the study.
干预措施: Elimination/Challenge Diet (Other)
结局指标
主要结局
Intra-individual agreement: food elimination challenge versus non-immunoglobulin E (IgE) mediated food allergy test results
时间窗: Weeks 5 through 9 is the challenge phase of the study. Results will be compared between the participants recorded symptoms during this phase to each challenged food item and the results of the non-IgE mediated food allergy test results from Week 1.
For each participant, a summary and analysis of agreement, using Cohen's kappa, will be undertaken comparing the results of each non-IgE mediated food allergy assessment method and the Elimination/Challenge diet for the 8 food items challenged. Similarly, secondary analysis will compare the degree of agreement between the intensity (high, medium, low and no reaction) on the non-IgE mediated food allergy results and the food reaction numerical scores.
次要结局
未报告次要终点
研究者
Deborah Kennedy
Principle Investigator
The Canadian College of Naturopathic Medicine