Whole food diet induces remission in children and young adults with mild-moderate Crohn's disease and is more tolerable than exclusive enteral nutrition: a randomized controlled trial

IF 25.7 1区 医学 Q1 GASTROENTEROLOGY & HEPATOLOGY
Yonat Aharoni Frutkoff, Luba Plotkin, Daniel Pollak, Jessica Livovsky, Gili Focht, Raffi Lev-Tzion, Oren Ledder, Amit Assa, Dotan Yogev, Esther Orlanski-Meyer, Efrat Broide, Jarosław Kierkuś, Ben Kang, Batia Weiss, Marina Aloi, Tobias Schwerd, Dror S. Shouval, Matteo Bramuzzo, Anne M. Griffiths, Moran Yassour, Dan Turner
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引用次数: 0

Abstract

Background

Tasty&Healthy (T&H) is a whole-food diet for Crohn’s disease (CD), which excludes processed food, gluten, red meat, and dairy, without requiring formula or mandatory ingredients. TASTI-MM was a clinician-blinded, randomized-controlled trial comparing tolerability and effectiveness of T&H vs. exclusive enteral nutrition (EEN).

Methods

Patients with biologic-naive mild-moderate CD aged 6–25 years were randomized to either T&H or EEN for 8 weeks, receiving weekly dietary support. Tolerability was evaluated by weekly interviews, questionnaires and intake diaries. Other outcomes included symptomatic remission, Mucosal-Inflammation Non-Invasive (MINI) index, calprotectin, C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). Fecal microbiome was analyzed by metagenomics at baseline, week-4 and week-8. Data were analyzed by the intention-to-treat approach unless specified otherwise.

Results

Among 83 included patients (41 T&H, 42 EEN; mean age 14.5±3.7 years), 88% tolerated T&H vs. 52% for EEN (aOR 7.7 [95%CI 2.4-25]; p<0.001). Calprotectin, CRP and ESR decreased significantly in both groups, with no between-group differences. Symptomatic remission was achieved in 56% of T&H group vs. 38% of the EEN group (aOR 2.5 [0.98-6.3], p=0.1; per-protocol: 67% vs. 76%; p=0.47). Calprotectin <250μg/g was achieved in 34% vs. 33% (aOR 0.97 [0.37-2.6], p=0.84) and MINI<8 in 44% vs. 31% (aOR 1.8 [0.7-4.5]; p=0.33). 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. Species associated with bowel inflammation, such as Ruminococcus gnavus, decreased in T&H and increased in EEN (q<0.001).

Conclusions

T&H demonstrated better tolerability than EEN for inducing remission in mild-to-moderate CD, while positively affecting the microbiome (TASTI-MM, NCT#04239248).
一项随机对照试验:全食物饮食诱导患有轻中度克罗恩病的儿童和年轻人缓解,并且比纯肠内营养更耐受
tasty&Healthy (T&;H)是一种针对克罗恩病(CD)的全食物饮食,不包括加工食品、麸质、红肉和乳制品,不需要配方或强制成分。ttasi - mm是一项临床盲法、随机对照试验,比较T&;H与单独肠内营养(EEN)的耐受性和有效性。方法6-25岁的生物源性轻中度CD患者随机分为T&;H组或EEN组,为期8周,每周接受饮食支持。通过每周访谈、问卷调查和服药日记来评估耐受性。其他结果包括症状缓解、粘膜炎症无创(MINI)指数、钙保护蛋白、c反应蛋白(CRP)和红细胞沉降率(ESR)。在基线、第4周和第8周采用宏基因组学分析粪便微生物组。除非另有说明,否则采用意向治疗法分析数据。结果83例患者中,T&;H 41例,EEN 42例;平均年龄14.5±3.7岁),88%耐受T&;H, 52%耐受EEN (aOR 7.7 [95%CI 2.4-25];术中,0.001)。两组钙护蛋白、CRP、ESR均显著降低,组间无差异。T&;H组症状缓解率为56%,EEN组为38% (aOR为2.5 [0.98-6.3],p=0.1;每个协议:67% vs. 76%;p = 0.47)。钙护蛋白250μg/g达到34%比33% (aOR 0.97 [0.37-2.6], p=0.84), mini8达到44%比31% (aOR 1.8 [0.7-4.5];p = 0.33)。微生物组α-多样性在T&;H组中有所提高,在EEN组中有所下降,在第4周和第8周均表现出优越的物种丰富度。与肠道炎症相关的菌种,如瘤状球菌(Ruminococcus gnavus),在T&;H中减少,而在EEN中增加(q<0.001)。结论st&;H在诱导轻度至中度CD缓解方面表现出比EEN更好的耐受性,同时积极影响微生物组(tsti - mm, NCT#04239248)。
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来源期刊
Gastroenterology
Gastroenterology 医学-胃肠肝病学
CiteScore
45.60
自引率
2.40%
发文量
4366
审稿时长
26 days
期刊介绍: Gastroenterology is the most prominent journal in the field of gastrointestinal disease. It is the flagship journal of the American Gastroenterological Association and delivers authoritative coverage of clinical, translational, and basic studies of all aspects of the digestive system, including the liver and pancreas, as well as nutrition. Some regular features of Gastroenterology include original research studies by leading authorities, comprehensive reviews and perspectives on important topics in adult and pediatric gastroenterology and hepatology. The journal also includes features such as editorials, correspondence, and commentaries, as well as special sections like "Mentoring, Education and Training Corner," "Diversity, Equity and Inclusion in GI," "Gastro Digest," "Gastro Curbside Consult," and "Gastro Grand Rounds." Gastroenterology also provides digital media materials such as videos and "GI Rapid Reel" animations. It is abstracted and indexed in various databases including Scopus, Biological Abstracts, Current Contents, Embase, Nutrition Abstracts, Chemical Abstracts, Current Awareness in Biological Sciences, PubMed/Medline, and the Science Citation Index.
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