Department of Gastroenterology, Dayanand Medical College and Hospital, Ludhiana, Punjab, India.
Department of Hepatology, Post Graduate Institute of Medical Education & Research, Chandigarh, India.
Trials. 2023 Aug 11;24(1):515. doi: 10.1186/s13063-023-07505-8.
Severe alcoholic hepatitis (SAH) is associated with high mortality. Numerous studies and meta-analysis have reported that corticosteroids reduce the 28-day mortality in SAH, but not the 6-month mortality. Therefore, newer treatments for SAH need to be studied. A pilot study from our group had recently treated ten patients with SAH with bovine colostrum (BC) [20 g thrice in a day for 8 weeks] and prednisolone. This therapy improved the biological functions and 3-month mortality. However, as more and more data showed the failure of corticosteroids to improve the 3- and 6-month mortality, especially in patients with high mDF and MELD scores, we planned this trial to study the safety and efficacy of BC (without corticosteroids) in the treatment of SAH.
This is a multicenter, parallel, double-blind, randomized (1:1) placebo-controlled trial, which will enroll 174 patients with SAH from 5 academic centers in the India. Patients will receive freeze-dried BC or placebo by random 1:1 allocation for 4 weeks. The primary outcome measure is survival at 3 months. The secondary outcome measures are survival at 1 month, change in mDF and MELD scores, change in endotoxin and cytokines (alpha TNF, IL6, and IL8) levels, number of episodes of sepsis [pneumonia, spontaneous bacterial peritonitis (SBP), cellulitis, urinary tract infection (UTI)] from baseline to 4 weeks.
This study will evaluate the safety and efficacy of bovine colostrum in improving the survival of patients with SAH.
ClinicalTrials.gov NCT02473341. Prospectively registered on June 16, 2015.
严重酒精性肝炎（SAH）与高死亡率相关。许多研究和荟萃分析报告称，皮质类固醇可降低 SAH 的 28 天死亡率，但不能降低 6 个月死亡率。因此，需要研究治疗 SAH 的新方法。我们小组最近进行了一项初步研究，用牛初乳（BC）[每天 3 次，每次 20 克，持续 8 周]和泼尼松龙治疗了 10 例 SAH 患者，该治疗改善了患者的生物学功能和 3 个月死亡率。然而，随着越来越多的数据表明皮质类固醇无法提高 3 个月和 6 个月的死亡率，尤其是在 MELD 和 mDF 评分较高的患者中，我们计划进行这项试验，以研究牛初乳（不含皮质类固醇）治疗 SAH 的安全性和疗效。
这是一项多中心、平行、双盲、随机（1:1）安慰剂对照试验，将从印度 5 个学术中心招募 174 例 SAH 患者。患者将通过随机 1:1 分配接受冻干牛初乳或安慰剂治疗 4 周。主要结局测量指标是 3 个月时的生存率。次要结局测量指标是 1 个月时的生存率、mDF 和 MELD 评分的变化、内毒素和细胞因子（TNF-α、IL6 和 IL8）水平的变化、从基线到 4 周时的败血症发作次数（肺炎、自发性细菌性腹膜炎（SBP）、蜂窝织炎、尿路感染（UTI））。
这项研究将评估牛初乳改善 SAH 患者生存率的安全性和有效性。
ClinicalTrials.gov NCT02473341。于 2015 年 6 月 16 日前瞻性注册。
