Effect, Tolerability, and Safety of Exclusive Palatable Elemental Diet in Patients With Intestinal Microbial Overgrowth

IF 12 1区医学 Q1 GASTROENTEROLOGY & HEPATOLOGY Clinical Gastroenterology and Hepatology Pub Date : 2025-11-01 Epub Date: 2025-04-04 DOI:10.1016/j.cgh.2025.03.002

Ali Rezaie , Bianca W. Chang , Juliana de Freitas Germano , Gabriela Leite , Ruchi Mathur , Krystyna Houser , Ava Hosseini , Daniel Brimberry , Mohamad Rashid , Sepideh Mehravar , Maria Jesus Villanueva-Millan , Maritza Sanchez , Stacy Weitsman , Cristina M. Fajardo , Ignacio G. Rivera , Lijin Joo , Yin Chan , Gillian M. Barlow , Mark Pimentel

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Abstract

Background & Aims

Elemental diets (EDs) have desirable safety and efficacy profiles in several clinical settings partly because of modulation of gut microbiome. Palatability of EDs remains the main barrier to compliance/adherence, and their effect has not been prospectively explored in microbiome-driven disorders, such as small intestinal bacterial overgrowth (SIBO) and intestinal methanogen overgrowth (IMO). We aimed to assess the effect, tolerance, and safety of a novel palatable ED (PED) in subjects with IMO and/or SIBO.

Methods

Adult subjects with positive lactulose breath tests for SIBO and/or IMO completed 1 week of screening, 2 weeks of exclusive oral PED, and 2 weeks of follow-up during reintroduction of regular diet. Primary end point was changes in stool microbiome after PED and reintroduction of regular diet. Secondary end points included tolerability, rate of normalization of lactulose breath tests, change in stool form based on daily diary and artificial intelligence-analyzed images, symptomatic response, and adverse events.

Results

All 30 enrolled subjects tolerated the PED and completed the trial. Several taxonomic differences were detected including decreased relative abundance of Prevotella_9 and Fusobacterium. Abundance of Methanobrevibacter smithii decreased at the end of the trial and correlated with average daily methane levels (P = .024; r = 0.489). Maximum methane levels (41 ± 35 to 12 ± 15 ppm; P < .001) and hydrogen rise (43 ± 42 to 12 ± 11 ppm; P < .001) dropped significantly, with 73% normalizing their lactulose breath tests. Adequate global relief of symptoms was reported in 83% of subjects. No serious or severe adverse events were observed.

Conclusions

PED significantly impacts the gut microbiome. Tolerance to EDs improves with enhanced palatability. Larger studies with longer follow-up are needed to assess response durability. (ClinicalTrials.gov ID: NCT05978973)

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纯美味元素饮食对肠道微生物过度生长患者的影响、耐受性和安全性。

背景与目的：元素饮食（EDs）在一些临床环境中具有良好的安全性和有效性，部分原因是肠道微生物组的调节。EDs的适口性仍然是依从性/依从性的主要障碍，并且它们在微生物组驱动的疾病（如小肠细菌过度生长（SIBO）和肠道甲烷菌过度生长（IMO））中的作用尚未被前瞻性探讨。我们的目的是评估一种新型可口ED （PED）在IMO和/或SIBO患者中的效果、耐受性和安全性。方法：乳果糖呼吸试验（LBT） SIBO和/或IMO阳性的成年受试者完成了一周的筛查，2周的独家口服PED，以及2周的随访，期间重新引入常规饮食。主要终点是PED和重新引入常规饮食后粪便微生物组的变化。次要终点包括耐受性、LBT正常化率、基于日常日记和人工智能分析图像的粪便形态变化、症状反应和不良事件。结果：所有30名受试者耐受PED并完成了试验。发现了几种分类差异，包括普雷沃氏菌和梭杆菌的相对丰度降低。在试验结束时，史密斯甲烷杆菌的丰度下降，并与平均每日甲烷水平相关（p=0.024, r=0.489）。最大甲烷含量（41±35 ~ 12±15 ppm, p）结论：PED显著影响肠道微生物群。对EDs的耐受性随着适口性的提高而提高。需要更大的研究和更长的随访时间来评估反应的持久性。（ClinicalTrials.gov ID: NCT05978973）。

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来源期刊

Clinical Gastroenterology and Hepatology 医学-胃肠肝病学

CiteScore

16.90

自引率

4.80%

发文量

903

审稿时长

22 days

期刊介绍： Clinical Gastroenterology and Hepatology (CGH) is dedicated to offering readers a comprehensive exploration of themes in clinical gastroenterology and hepatology. Encompassing diagnostic, endoscopic, interventional, and therapeutic advances, the journal covers areas such as cancer, inflammatory diseases, functional gastrointestinal disorders, nutrition, absorption, and secretion. As a peer-reviewed publication, CGH features original articles and scholarly reviews, ensuring immediate relevance to the practice of gastroenterology and hepatology. Beyond peer-reviewed content, the journal includes invited key reviews and articles on endoscopy/practice-based technology, health-care policy, and practice management. Multimedia elements, including images, video abstracts, and podcasts, enhance the reader's experience. CGH remains actively engaged with its audience through updates and commentary shared via platforms such as Facebook and Twitter.