Tuberculosis-Learning the Impact of Nutrition (TB LION): protocol for an interventional study to decrease TB risk in household contacts.

Tuberculosis-Learning the Impact of Nutrition (TB LION): protocol for an interventional study to decrease TB risk in household contacts.
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DOI:
10.1186/s12879-021-06734-z
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发表时间:
2021-10-12
影响因子:
3.7
通讯作者:
Hochberg NS
Hochberg NS
中科院分区:
医学3区
文献类型:
--
作者:
Cintron C;Narasimhan PB;Locks L;Babu S;Sinha P;Rajkumari N;Kaipilyawar V;Bhargava A;Maloomian K;Chandrasekaran P;Verma S;Joseph N;Johnson WE;Wanke C;Horsburgh CR Jr;Ellner JJ;Sarkar S;Salgame P;Lakshminarayanan S;Hochberg NS

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营养不良和寄生虫感染等合并症在印度和其他结核病流行国家很普遍。这项研究探讨了这些条件以及食品补充剂和寄生虫治疗如何改变对结核分枝杆菌 (Mtb) 感染的免疫反应以及进展为结核病的风险。这是在印度泰米尔纳德邦本地治里贾瓦哈拉尔研究生医学教育与研究研究所进行的一项为期 5 年的前瞻性临床试验。我们的目标是招募 760 名患有活动性结核病的成年人的家庭接触者 (HHC),以便确定 120 名患者进行为期 2 年的前瞻性随访:30 名 QuantiFERON-TB Gold Plus (QFT-Plus) 阳性 HHC,年龄≥18 岁,分为四个建议组:(1) 营养不良(体重指数 [BMI] < 18.5 kg/m2); (2) BMI ≥ 18.5 kg/m2 且患有寄生虫感染的参与者 (3) 营养不良且患有寄生虫感染的参与者,以及 (4) 对照——BMI ≥ 18.5 kg/m2 但未感染寄生虫的参与者。我们评估基线和食物补充剂(对于 BMI< 18.5 kg/m2 的参与者)和寄生虫治疗(对于患有寄生虫的参与者)后的免疫反应。通过聚合酶链反应 (PCR) 和显微镜进行详细的营养评估、人体测量和寄生虫测试。此外,在连续的时间点,将使用流式细胞术和全血转录组学进一步分析这些样本,以阐明疾病进展中涉及的免疫机制。这项研究将有助于确定营养不良和寄生虫感染是否与预测结核病风险的基因特征有关,以及提供营养补充和/或治疗寄生虫感染是否可以改善针对这种感染的免疫反应。这项研究超越了个人护理水平,通过分析影响疾病进展的因素,有可能减轻结核病患者的总体负担,从而为广大人群提供了造福的机会。试验注册 ClinicalTrials.gov; NCT03598842; 2018年7月26日注册; https://clinicaltrials.gov/ct2/show/NCT03598842 在线版本包含可在 10.1186/s12879-021-06734-z 获取的补充材料。
Comorbidities such as undernutrition and parasitic infections are widespread in India and other tuberculosis (TB)-endemic countries. This study examines how these conditions as well as food supplementation and parasite treatment might alter immune responses to Mycobacterium tuberculosis (Mtb) infection and risk of progression to TB disease. This is a 5-year prospective clinical trial at Jawaharlal Institute of Post Graduate Medical Education and Research in Puducherry, Tamil Nadu, India. We aim to enroll 760 household contacts (HHC) of adults with active TB in order to identify 120 who are followed prospectively for 2 years: Thirty QuantiFERON-TB Gold Plus (QFT-Plus) positive HHCs ≥ 18 years of age in four proposed groups: (1) undernourished (body mass index [BMI] < 18.5 kg/m2); (2) participants with a BMI ≥ 18.5 kg/m2 who have a parasitic infection (3) undernourished participants with a parasitic infection and (4) controls—participants with BMI ≥ 18.5 kg/m2 and without parasitic infection. We assess immune response at baseline and after food supplementation (for participants with BMI < 18.5 kg/m2) and parasite treatment (for participants with parasites). Detailed nutritional assessments, anthropometry, and parasite testing through polymerase chain reaction (PCR) and microscopy are performed. In addition, at serial time points, these samples will be further analyzed using flow cytometry and whole blood transcriptomics to elucidate the immune mechanisms involved in disease progression. This study will help determine whether undernutrition and parasite infection are associated with gene signatures that predict risk of TB and whether providing nutritional supplementation and/or treating parasitic infections improves immune response towards this infection. This study transcends individual level care and presents the opportunity to benefit the population at large by analyzing factors that affect disease progression potentially reducing the overall burden of people who progress to TB disease. Trial registration ClinicalTrials.gov; NCT03598842; Registered on July 26, 2018; https://clinicaltrials.gov/ct2/show/NCT03598842 The online version contains supplementary material available at 10.1186/s12879-021-06734-z.
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