OP019. Efficacy and safety of oral tofacitinib as induction therapy in patients with moderate-to-severe ulcerative colitis: results from 2 phase 3 randomised controlled trials
Bibliographic record
Abstract
Background: We have demonstrated an extensive modulation of gut microbiome in children with Crohn's disease on induction treatment with exclusive enteral nutrition (EEN) (1,2).This observation offers clues about the potential mode of EEN action and advocates towards the development of novel therapies through dietary manipulation of the gut microbiota.This crossover, RCT compared the effect of a novel 'ordinary' food-based diet (CD-TREAT diet) and EEN on healthy gut microbiota.Methods: Healthy adults followed 2 experimental diets for 7 days with a 15-day washout period in between: EEN and CD-TREAT, an 'ordinary' food diet that has similar nutrient and food ingredient composition to EEN (eg, fibre content, fatty acid composition, and lactose-and gluten-free content).Participants were randomly allocated to start with EEN or CD-TREAT first.Fresh faecal samples were collected before and after each dietary intervention (4 different time points), and faecal short chain fatty acids (SCFA), pH, ammonia, and sulphide were measured.Results: From 25 healthy subjects, 100 samples were collected.Faecal concentration of total SCFA and acetic, propionic, butyric, and caproic acid significantly decreased during both dietary interventions (ΔMedian μmol/g; EEN, -167.27,-135.61,-15.47, -21.01, -2.02, vs CD-TREAT, -165.18,-68.92, -25.5, -34.99, -1.36, all p < 0.01).Proportional ratio (% of total SCFA) was significantly reduced for butyric and caproic acid (ΔMedian %: EEN, -2.92%, -0.47%; CD-TREAT, -5.04%, -0.21%, all p <0.01); but did not change for the other SCFA.Faecal concentration of iso-butyric and iso-valeric acid was significantly increased after EEN only (ΔMedian μmol/g; EEN, 2.33, 2.59), whilst their proportional ratio increased after both diets (ΔMedian %; EEN, 1.95%, 2.13%; CD-TREAT, 0.72%, 0.88%, all p < 0.001).Faecal pH significantly changed from a neutral baseline level to the alkaline range (ΔMedian pH units; EEN, 1.39, vs CD-TREAT, 0.97, both p < 0.001).Likewise, total sulphide significantly increased during both diets (ΔMedian μmol/g; EEN, 3.1; CD-TREAT, 0.92, both p < 0.001).Faecal ammonia and free sulphide concentration did not differ between the 4 time points. Conclusions:We have developed an 'EEN composition alike' foodbased diet which induces similar effects on gut microbial metabolites with EEN.Further analysis including high-throughput deep sequencing techniques will provide additional scientific evidence before we move this novel dietary treatment towards a subsequent clinical trial in people with active CD.
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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 | 0.005 | 0.005 |
| Meta-epidemiology (narrow) | 0.001 | 0.001 |
| Meta-epidemiology (broad) | 0.004 | 0.004 |
| Bibliometrics | 0.001 | 0.001 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.002 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.003 | 0.003 |
| Insufficient payload (model declined to judge) | 0.008 | 0.001 |
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".