Modified Crohn’s Disease Exclusion Diet Maintains Remission in Pediatric Crohn’s Disease: Randomized Controlled Trial
Bibliographic record
Abstract
BACKGROUND & AIMS: The Crohn's disease exclusion diet (CDED) + partial enteral nutrition (PEN) is effective for inducing remission in mild-moderate Crohn's disease (CD). We assessed whether a 2-week course of exclusive enteral nutrition (EEN) followed by CDED+PEN is superior to 8 weeks of EEN in sustaining clinical remission at week 14 in mild-to-severe CD and if CDED+PEN can maintain remission to week 24. METHODS: This international, multicenter, randomized controlled trial compared 2 weeks of EEN (Modulen IBD) followed by 3 phases of the CDED+PEN (henceforth CDED) to 8 weeks of EEN, followed by PEN with free diet up to week 24 (henceforth EEN). RESULTS: Out of 64 eligible patients, 56 were randomized (target recruitment failed due to the COVID-19 pandemic, leading to an underpowered study): 30 patients to CDED and 26 to EEN. The primary endpoint at week 14 showed no significant difference between the groups, with sustained corticosteroid-free remission in 21 (70%) of 30 for CDED compared with 16 (61.5%) of 26 for EEN (P = .5). At week 8, clinical remission was achieved in 23 (77%) of 30 CDED patients vs 14 (54%) of 26 EEN patients (P = .07), and 18 (60%) of 30 CDED patients vs 11 (42%) of 26 EEN patients maintained clinical remission to week 24 (P = .18). The body mass index Z score significantly improved in the CDED group but not in the EEN group. CONCLUSIONS: The study was underpowered to show whether CDED was superior to EEN in sustaining remission. However, 2 weeks of EEN followed by CDED was effective in inducing remission in CD, with most CDED patients maintaining remission up to 24 weeks. Despite dietary restrictions for 24 weeks, the body mass index Z score improved significantly in the CDED group but not in the EEN group (NCT02843100).
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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 | 0.001 | 0.002 |
| Meta-epidemiology (narrow) | 0.002 | 0.001 |
| Meta-epidemiology (broad) | 0.007 | 0.003 |
| Bibliometrics | 0.000 | 0.001 |
| Science and technology studies | 0.001 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.001 |
| Research integrity | 0.002 | 0.004 |
| Insufficient payload (model declined to judge) | 0.007 | 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".