Rezaie Ali, Chang Bianca W, de Freitas Germano Juliana, Leite Gabriela, Mathur Ruchi, Houser Krystyna, Hosseini Ava, Brimberry Daniel, Rashid Mohamad, Mehravar Sepideh, Villanueva-Millan Maria Jesus, Sanchez Maritza, Weitsman Stacy, Fajardo Cristina M, Rivera Ignacio G, Joo Lijin, Chan Yin, Barlow Gillian M, Pimentel Mark
Medically Associated Science and Technology (MAST) Program, Cedars-Sinai, Los Angeles, California; Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai, Los Angeles, California.
Karsh Division of Gastroenterology and Hepatology, Department of Medicine, Cedars-Sinai, Los Angeles, California.
Clin Gastroenterol Hepatol. 2025 Apr 4. doi: 10.1016/j.cgh.2025.03.002.
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).
背景与目的：要素饮食（EDs）在多种临床环境中具有良好的安全性和有效性，部分原因是其对肠道微生物群的调节作用。要素饮食的适口性仍然是依从性/坚持性的主要障碍，并且其在微生物群驱动的疾病，如小肠细菌过度生长（SIBO）和肠道产甲烷菌过度生长（IMO）中的作用尚未得到前瞻性研究。我们旨在评估一种新型适口要素饮食（PED）对患有IMO和/或SIBO的受试者的效果、耐受性和安全性。 方法：乳糖呼气试验阳性的SIBO和/或IMO成年受试者完成1周的筛查、2周的纯口服PED以及恢复常规饮食后的2周随访。主要终点是PED和恢复常规饮食后粪便微生物群的变化。次要终点包括耐受性、乳糖呼气试验正常化率、基于每日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名入组受试者均耐受PED并完成试验。检测到一些分类学差异，包括普雷沃氏菌属9和梭杆菌属相对丰度降低。试验结束时，史氏甲烷短杆菌的丰度降低，且与平均每日甲烷水平相关（P = 0.024；r = 0.489）。最大甲烷水平（4１±35至12±15 ppm；P < 0.001）和氢气上升量（43±42至12±11 ppm；P < 0.001）显著下降，73%的受试者乳糖呼气试验恢复正常。83%的受试者报告症状得到充分缓解。未观察到严重或重度不良事件。 结论：PED对肠道微生物群有显著影响。要素饮食的耐受性随着适口性的提高而改善。需要进行更大规模、更长随访期的研究来评估反应的持久性。（ClinicalTrials.gov标识符：NCT05978973）
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