Whole Food Diet Induces Remission in Children and Young Adults With Mild to Moderate Crohn's Disease and Is More Tolerable Than Exclusive Enteral Nutrition: A Randomized Controlled Trial.

TASTI-MM was a clinician-blinded, randomized controlled trialcomparing tolerability and effectiveness of T&H vs exclusive enteral nutrition (EEN).

TASTI-MM 是一项临床医生盲法、随机对照试验，比较了 T&H 与全肠内营养（EEN）的耐受性和有效性。

Methods

Patients with biologic-naïve mild to moderate CD and aged 6-25 years were randomized to either T&H or EEN for 8 weeks, receiving weekly dietary support.

随机分配到T&H或EEN治疗8周的生物未治疗的轻度至中度CD患者，年龄在6-25岁之间，每周接受饮食支持。

Tolerability was evaluated by weekly interviews, questionnaires, and intake diaries.

耐受性通过每周访谈、问卷和摄入日记进行评估。

Other outcomes included symptomatic remission, Mucosal-Inflammation Noninvasive index, calprotectin, C-reactive protein, and erythrocyte sedimentation rate.

其他结果包括症状缓解、粘膜炎症非侵入性指数、钙结合蛋白、C反应蛋白和红细胞沉降率。

Fecal microbiome was analyzed by metagenomics at baseline, week 4, and week 8.

基线时、第4周和第8周通过宏基因组学分析粪便微生物组。

Data were analyzed by the intention-to-treatapproach unless specified otherwise.

除非另有说明，否则数据分析采用意向治疗分析方法。

Results

Among 83 included patients (n = 41 T&H, n = 42 EEN; mean ± SD age, 14.5 ± 3.7 years), 88% tolerated T&H vs 52% for EEN (adjusted odds ratio [aOR], 7.7; 95% CI, 2.4-25; P < .001).

在纳入的83名患者中（T&H组41人，EEN组42人；平均年龄±标准差为14.5±3.7岁），88%的患者能够耐受T&H治疗，而EEN治疗的耐受率为52%（调整后的优势比[aOR]为7.7；95%置信区间为2.4-25；P < .001）。

Calprotectin, C-reactive protein, and erythrocyte sedimentation rate decreased significantly in both groups, with no between-group differences.

两组的钙结合蛋白、C反应蛋白和红细胞沉降率均显著下降，组间差异无统计学意义。

Symptomatic remission was achieved in 56% of the T&H group vs 38% of the EEN group (aOR, 2.5; 95% CI, 0.98-6.3; P = .1; per-protocol: 67% vs 76%; P = .47).

T&H组有56%的患者达到症状缓解，而EEN组为38%（调整后比值比，2.5；95%置信区间，0.98-6.3；P = .1；按方案分析：67%对76%；P = .47）。

Calprotectin <250 μg/g was achieved in 34% vs 33% (aOR, 0.97; 95% CI, 0.37-2.6; P = .84) and Mucosal-Inflammation Noninvasive index score <8 in 44% vs 31% (aOR, 1.8; 95% CI, 0.7-4.5; P = .33).

在 34% vs 33% 的患者中实现了 Calprotectin <250 μg/g (aOR, 0.97; 95% 置信区间, 0.37-2.6; P = .84)，并且在 44% vs 31% 的患者中实现了粘膜炎症无创指数评分 <8 (aOR, 1.8; 95% 置信区间, 0.7-4.5; P = .33)。

Microbiome α-diversity improved in the T&H arm and declined in the EEN arm, showing superior species richness at both week 4 and week 8.

T&H 组的微生物群α多样性在第4周和第8周均有所改善，而在 EEN 组中则有所下降，显示出在两个时间点上物种丰富度更优。

Species associated with bowel inflammation, such as Ruminococcus gnavus, decreased in T&H and increased in EEN (q < .001).

与肠道炎症相关的物种，如Ruminococcus gnavus，在T&H中减少，在EEN中增加（q < .001）。

Conclusions

T&H demonstrated better tolerability than EEN for inducing remission in mild to moderate CD, while positively affecting the microbiome.

T&H在诱导轻度至中度CD缓解方面显示出比EEN更好的耐受性，同时对微生物群产生积极影响。

clinicaltrials

gov, Number: NCT04239248.

政府注册号：NCT04239248。