A fasting-mimicking diet in patients with mild-to-moderate Crohn's disease: a randomized controlled trial.

Potential benefits of FMD have not been investigated in Crohn's disease (CD).

FMD的潜在益处尚未在克罗恩病（CD）中进行研究。

We conducted an open-label, randomized, controlled trial to assess the effects of FMD in adults with mild-to-moderate CD.

我们开展了一项开放标签、随机对照试验，以评估轻度至中度克罗恩病（CD）成人患者采用禁食模拟饮食（FMD）的效果。

Patients in the FMD group followed an FMD for five consecutive days per month for three consecutive months, returning to their regular baseline diet on non-FMD days.

FMD组的患者每月连续五天进行FMD，持续三个月，非FMD日则恢复到常规基础饮食。

Control participants continued their baseline diet.

对照组参与者继续他们的基线饮食。

The primary outcome of clinical response was a reduction in CD Activity Index (CDAI) of at least 70 points or CDAI of ≤150 after the third 5-day diet cycle.

临床反应的主要结果是在第三次5天饮食周期后，克罗恩病活动指数（CDAI）至少减少70点或CDAI≤150。

Forty-five patients in the FMD group (69.2%) and 14 patients in the control group (43.8%) met the primary outcome of clinical response (P = 0.03).

FMD组中有45名患者（69.2%）和对照组中有14名患者（43.8%）达到了临床反应的主要结果（P = 0.03）。

Forty-two patients in the FMD group (64.6%) and 12 patients in the control group (37.5%) achieved the secondary outcome of clinical remission (P = 0.02).

FMD组中有42名患者（64.6%）和对照组中有12名患者（37.5%）实现了临床缓解的次要结果（P = 0.02）。

There was also a decline from baseline in fecal calprotectin (an inflammatory marker) in the FMD group compared with the control group (-22.0% versus 8.0%, P = 0.03).

在FMD组中，与对照组相比，粪便钙卫蛋白（一种炎症标志物）从基线开始下降（-22.0%对比8.0%，P=0.03）。

Exploratory analyses of plasma metabolites and peripheral blood mononuclear cell gene expression revealed post-FMD decreases in key inflammatory lipid mediators and immune-effector transcripts, concordant with reduced CD activity.

对血浆代谢物和外周血单个核细胞基因表达的探索性分析揭示了FMD后关键炎症性脂质介质和免疫效应分子转录本的下降，与CD活性降低一致。

Together, these findings demonstrate that FMD is superior to a baseline diet for inducing clinical response, clinical remission and biochemical improvement in mild-to-moderate CD, and support further investigation of FMD as an adjunctive therapy for chronic inflammatory diseases.

这些发现共同表明，与基线饮食相比，FMD在诱导轻度至中度克罗恩病的临床反应、临床缓解和生化改善方面更为优越，并支持进一步研究FMD作为慢性炎症性疾病辅助治疗的潜力。

ClinicalTrials.gov registration: NCT04147585 .

ClinicalTrials.gov 注册号：NCT04147585。