A Novel, IBS-Specific IgG ELISA-Based Elimination Diet in Irritable Bowel Syndrome: A Randomized, Sham-Controlled Trial.

However, existing studies have serious methodological limitations.

然而，现有的研究存在严重的的方法学局限性。

This study aimed to assess the efficacy of an elimination diet by using a novel IBS-specific IgG assay.

本研究旨在通过使用一种新的肠易激综合征（IBS）特异性IgG检测方法，评估消除饮食的疗效。

Methods

We conducted a randomized, double-blind, sham-controlled trial enrolling subjects with IBS from 8 centers.

我们进行了一项随机、双盲、安慰剂对照试验，招募了来自8个中心的肠易激综合征（IBS）患者。

Subjects positive for ≥1 food on an 18-food IgG assay and an average daily abdominal pain intensity score between 3.0 and 7.5 on an 11.0-point scale during a 2-week run-in period were randomized to either an experimental antibody-guided diet or sham diet for 8 weeks.

在为期2周的启动期内，对18种食物IgG检测呈阳性的受试者（≥1种食物），以及平均每日腹痛强度评分为3.0至7.5（11.0分量表），随机分配至实验性抗体指导饮食或安慰剂饮食，持续8周。

The primary outcome was a ≥30% decrease in abdominal pain intensity for ≥2 of the last 4 weeks of the treatment period.

主要结果是治疗期间最后4周中有≥2周腹痛强度下降≥30%。

Results

Among 238 randomized subjects with IBS, 223 were included in the modified intention-to-treatanalysis.

在238名随机分配的肠易激综合症（IBS）患者中，有223名被纳入改良意向治疗分析。

A significantly greater proportion of subjects in the experimental diet group met the primary outcome than those in the sham diet group (59.6% vs 42.1%, P = .02).

实验饮食组中达到主要终点的患者比例显著高于安慰剂饮食组（59.6% vs 42.1%，P = .02）。

Subgroup analysis revealed that a higher proportion of subjects with constipation-predominant IBS and IBS with mixed bowel habits in the experimental diet group met the primary endpoint vs the sham group (67.1% vs 35.8% and 66% vs 29.5%, respectively).

亚组分析显示，实验饮食组中便秘型肠易激综合症和混合型肠易激综合症的患者达到主要终点的比例高于安慰剂组（分别为67.1%对35.8%和66%对29.5%）。

Conclusions

Subjects on an IgG-guided elimination diet were more likely to achieve the primary endpoint than those on a sham elimination diet.

接受IgG指导的消除饮食的受试者比接受安慰剂消除饮食的受试者更有可能达到主要终点。

Subgroup analysis suggests a more robust benefit for subjects with constipation-predominant IBS and IBS with mixed bowel habits.

亚组分析表明，便秘型肠易激综合征（IBS）和混合型IBS患者受益更为显著。

This highlights the potential effectiveness of a personalized elimination diet based on a novel IBS-specific IgG assay.

这突显了基于新型IBS特异性IgG检测的个性化排除饮食的潜在有效性。

A larger study is warranted to validate these observations.

需要更大规模的研究来验证这些观察结果。

(ClinicalTrials.gov, Number NCT03459482.).

（ClinicalTrials.gov, 注册号NCT03459482）。