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

• DOI: 10.1016/j.cgh.2025.03.002
• Publication Date: 2025-04-06T23:34:57Z
• Authors: Ali Rezaie; Bianca W. Chang; Juliana de Freita...; Gabriela Leite; Ruchi Mathur; Krystyna Houser; Ava Hosseini; Daniel Brimberry; Mohamad Rashid; Sepideh Mehravar; Maria Jesus Villa...; Maritza Sanchez; Stacy Weitsman; Cristina M. Fajardo; Ignacio G. Rivera; Lijin Joo; Yin Chan; Gillian M. Barlow; Mark Pimentel
• Keywords: Tolerability; Elemental diet

Elemental diets (EDs) have desirable safety and efficacy profiles in several clinical settings partly due to modulation of gut microbiome. Palatability EDs remains the main barrier compliance/adherence, their effect has not been prospectively explored microbiome-driven disorders such as small intestinal bacterial overgrowth (SIBO) methanogen (IMO). We aimed assess effect, tolerance, a novel palatable ED (PED) subjects with IMO and/or SIBO. Adult positive lactulose breath tests (LBT) for SIBO completed one week screening, 2 weeks exclusive oral PED, follow-up during reintroduction regular diet. Primary endpoint was changes stool microbiome after PED Secondary endpoints included tolerability, rate normalization LBT, change form based on daily diary artificial intelligence-analyzed images, symptomatic response, adverse events. All 30 enrolled tolerated trial. Several taxonomic differences were detected including decreased relative abundance Prevotella_9 Fusobacterium. Abundance Methanobrevibacter smithii at end trial correlated average methane levels (p=0.024, r=0.489). Maximum (41±35 12±15 ppm, p<0.001) hydrogen rise (43±42 12±11 dropped significantly, 73% normalizing LBT. Adequate global relief symptoms reported 83% subjects. No serious or severe events observed. significantly impacts Tolerance improve enhanced palatability. Larger studies longer are needed response durability. (ClinicalTrials.gov ID: NCT05978973).