Background While nutritional interventions with prebiotics and probiotics seem to exert immunological effects, their clinical implications in human immunodeficiency virus (HIV)-infected subjects initiating antiretroviral therapy (ART) at advanced HIV disease remain unclear. Methods This was a pilot multicenter randomized, placebo-controlled, double-blind study in which 78 HIV-infected, ART-naive subjects with <350 CD4 T cells/μL or AIDS were randomized to either daily PMT25341 (a mixture of synbiotics, omega-3/6 fatty acids and amino acids) or placebo for 48 weeks, each in combination with first-line ART. Primary endpoints were changes in CD4 T-cell counts and CD4/CD8 ratio from baseline to week 48 and safety. Secondary endpoints were changes in markers of T-cell activation, bacterial translocation, inflammation, and α and β microbiota diversity. Results Fifty-nine participants completed the follow-up with a mean CD4+ T-cell count of 221 ± 108 cells/μL and mean CD4/CD8 ratio of 0.26 ± 0.19. PMT25341 was well tolerated, without grade 3-4 adverse effects attributable to the intervention. While most of the assessed biomarkers improved during the follow-up in both arms, PMT25341-treated subjects did not experience any significant change, compared to placebo-treated subjects, in mean CD4+ T-cell count change (278 vs 250 cells/μL, P = .474) or CD4/CD8 ratio change (0.30 vs 0.32, P = .854). Similarly, we did not detect differences between treatment arms in secondary endpoints. Conclusions In HIV-infected patients initiating ART at advanced disease, the clear immunological benefits of ART were not enhanced by this nutritional intervention targeting the gut-associated lymphoid tissue and microbiota. Clinical Trials Registration NCT00870363.

中文翻译：

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免疫营养在晚期人类免疫缺陷病毒疾病中的作用：随机安慰剂对照临床试验（青春期研究）。

背景技术虽然益生元和益生菌的营养干预措施似乎具有免疫学作用，但对于在晚期HIV疾病中开始抗逆转录病毒治疗（ART）的人类免疫缺陷病毒（HIV）感染受试者的临床意义尚不清楚。方法这是一项多中心，安慰剂对照，双盲的先导性随机研究，其中78名HIV感染，ART初次接受试验的受试者中＜350 CD4 T细胞/μL或AIDS的患者被随机分配至每日PMT25341（一种合生素，ω -3/6脂肪酸和氨基酸）或安慰剂治疗48周，每种均与一线抗逆转录病毒疗法联合使用。主要终点是从基线到第48周CD4 T细胞计数和CD4 / CD8比值的变化以及安全性。次要终点是T细胞活化，细菌易位，炎症，和α和β微生物群的多样性。结果59名参与者完成了随访，平均CD4 + T细胞计数为221±108细胞/μL，平均CD4 / CD8比为0.26±0.19。PMT25341的耐受性良好，没有因干预而导致的3-4级不良反应。尽管大多数评估的生物标志物在随访中均得到改善，但与安慰剂治疗组相比，PMT25341治疗组的受试者平均CD4 + T细胞计数没有明显变化（278 vs 250细胞/μL， P = .474）或CD4 / CD8比值变化（0.30对0.32，P = .854）。同样，我们也没有在次要终点发现治疗臂之间的差异。结论在晚期疾病中开始接受ART的HIV感染患者中，这种针对肠道相关淋巴组织和微生物群的营养干预措施并未增强ART的明显免疫学益处。临床试验注册NCT00870363。