医学
内科学
双盲
胃肠病学
安慰剂
溃疡性结肠炎
临床试验
皮肤病科
疾病
病理
替代医学
作者
Saurabh Kedia,Shubi Virmani,Aditya Bajaj,Manasvini Markandey,Neha Singh,Divya Madan,Kanav Kaushal,Pabitra Sahu,Sudheer K. Vuyyuru,Bhaskar Kante,Peeyush Kumar,David Mathew Thomas,Sandeep Mundhra,Mukesh Kumar Singh,M Verma,Raju Sharma,Prasenjit Das,Nihar Ranjan Dash,Nitika Monga,Amit Awasthi,Govind Makharia,Vineet Ahuja
标识
DOI:10.1016/j.cgh.2024.01.013
摘要
Background and Aims Coconut water is anti-inflammatory, can manipulate the gut microbiome and is a rich source of potassium. Gut microbiome modulation improves outcomes in UC, and potassium possesses in vitro anti-inflammatory property. We evaluated the effect of coconut water as an adjunct therapy for patients with mild-moderate UC. Methods This single-center double-blind placebo-controlled trial randomized patients with mild-moderate(simple clinical colitis activity index-SCCAI:3–9) endoscopically active UC(ulcerative colitis endoscopic index of severity-UCEIS>1) in 1:1 ratio to coconut water + standard medical therapy-SMT(CW) vs placebo + SMT. 400ml of coconut water was administered for 8weeks. Primary outcome measure was clinical remission(SCCAI ≤ 2) and secondary outcome measures were clinical response(SCCAI decline ≥ 3) and adverse events at 8weeks. Microbiome was analyzed at baseline and 8weeks. Results Of 121 patients screened, 95 were included for modified intention to treat analysis(49-CW, 46-placebo)[mean age-37.2 ± 11.2years; males-54.1%; disease duration-48(IQR:24–90)months; pancolitis-26.1%; SCCAI-5(IQR:4 – 6); UCEIS-4(IQR:3 – 5)]. Clinical response[57.1% vs 28.3%, p=0.01, OR-3.4(95%CI:1.4 – 7.9)], remission[53.1% vs 28.3%, p=0.02, OR-2.9(95%CI:1.2 – 6.7)] and proportion of patients with fecal calprotectin(FCP)<150μg/g[30.6% vs 6.5%, p=0.003, OR-6.3(95%CI:1.7 – 23.6)] were significantly higher in CW. The relative abundance of bacterial taxa which had a significant or trend towards negative correlation with SCCAI, UCEIS, or FCP, increased at 8weeks in CW, and this effect was independent of disease activity and dietary fiber. Adverse events were comparable and no patient developed hyperkalemia. Conclusion Coconut water was more effective than placebo for induction of clinical remission in patients with mild to moderate UC. The trial was prospectively registered on clinical trials registry India (No: CTRI/2019/03/01827)
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