A Test of Iron Malabsorption in Patients with IDA

IDA 患者铁吸收不良的测试

• 批准号: 6879868
• 负责人: MORTEZA JANGHORBANI
• 金额: $ 19.86万
• 依托单位: BIOCHEMANALYSIS CORPORATION
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2008-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6879868
• 关键词: clinical research; diagnosis design /evaluation; diagnosis quality /standard; dietary iron; feces analysis; female; gastrointestinal nutrient absorption; human subject; malabsorption; microcytic /hypochromic anemia; noninvasive diagnosis; radionuclide diagnosis; women' s health

DESCRIPTION (provided by applicant): Iron deficiency anemia (IDA) is a major problem among adults and elderly. In men and postmenopausal women, IDA is currently thought to result from gastrointestinal (GI) blood loss. Despite thorough GI tract evaluation, a significant number of patients are found to be negative for fecal occult blood (FOB) and >30% do not have lesions consistent with chronic blood loss, suggesting that iron (Fe) malabsorption plays an important role. Currently, however, there is neither a suitable test to measure Fe absorption nor a role in the present scheme of GI examination for its evaluation. We propose to modify the current protocol for FOB testing to permit concurrent evaluation of both FOB and Fe absorption in a noninvasive test. The modification involves ingesting a gelatin capsule at bedtime that contains small quantities of Fe labeled with a non-radioactive (stable) isotope (Fe ), the recently developed nonabsorbable marker DyCl3, and the food colorant (visual stool marker) FD&C Blue No. 1.This is followed by laboratory analysis of a small sample of the visually marked stool for blood (the current practice) and the ratio Fe*/Dy; the latter provides accurate information on presence of iron malabsorption. During Phase-I, we will test the feasibility of this method by establishing the expectedly high value of iron absorption in healthy pre-menopausal women who are iron deficient without involvement of the GI tract. During Phase-II, we will evaluate the range of iron malabsorption that exists in IDA patients with suspected malabsorption (e.g celiac disease, H. pylori gastritis, or IDA patients refractory to iron supplementation, etc.) and in appropriate "controls" (IDA patients without malabsorption). During Phase-Ill, we will manufacture a "Test Kit', obtain FDA approval and work with the GI community to develop applications for measurement of iron malabsorption in the evaluation of IDA patients using private funds.

描述（由申请人提供）：缺铁性贫血（IDA）是成人和老年人的主要问题。在男性和绝经后女性中，IDA目前被认为是胃肠道（GI）失血所致。尽管进行了全面的胃肠道评估，但发现大量患者的粪便潜血（FOB）呈阴性，并且>30%的患者没有与慢性失血一致的病变，这表明铁（Fe）吸收不良起着重要作用。然而，目前既没有合适的测试来测量铁吸收，也没有在目前的GI检查计划中的作用，以进行评估。我们建议修改目前的协议FOB测试，允许同时评估FOB和铁吸收的非侵入性测试。修改涉及在睡前服用明胶胶囊，其中含有少量的铁标记的非放射性（稳定）同位素（铁），最近开发的不可吸收的标记物DyCl 3，和食品着色剂（可见粪便标记物）FD&C蓝1号。随后对可见标记的粪便的小样本进行实验室分析以检测血液（当前实践）和Fe*/Dy比率;后者提供关于铁吸收不良存在的准确信息。在第一阶段，我们将通过在不涉及胃肠道的铁缺乏的健康绝经前妇女中建立非常高的铁吸收值来测试这种方法的可行性。在第二阶段，我们将评估疑似吸收不良的IDA患者中存在的铁吸收不良的范围（例如，乳糜泻，H。幽门螺杆菌性胃炎，或缺铁性贫血患者难以补充铁等）和适当的“对照”（IDA患者无吸收不良）。在第三阶段，我们将制造一个“测试套件”，获得FDA的批准，并与GI社区合作，利用私人资金开发用于评估IDA患者的铁吸收不良测量应用程序。