Effect, Tolerability, and Safety of Exclusive Palatable Elemental Diet in Patients With Intestinal Microbial Overgrowth
Bibliographic record
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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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.001 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.001 | 0.001 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.001 |
| Insufficient payload (model declined to judge) | 0.001 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".