OP02 Tasty & Healthy Flexible Diet Induces clinical and biological Remission in Children and Young Adults with Mild-Moderate Crohn's Disease similar to EEN: results from the "TASTI-MM" randomized, physician-blinded, controlled trial
Bibliographic record
Abstract
Abstract Background Exclusive enteral nutrition (EEN) is effective for inducing remission in Crohn's disease (CD) but has adherence challenges. The CD-Exclusion Diet (CDED) is an effective alternative but requires partial enteral nutrition (PEN) with formula and mandatory ingredients. The Tasty&HealthyTM (T&H) diet excludes processed food, gluten, red meat, and dairy (except plain yogurt) without mandatory ingredients or PEN. This randomized controlled trial assessed the tolerability and effectiveness of the T&H diet compared to EEN in children and young adults with CD (NCT#04239248; TASTI-MM, T&H to Induce remission in Mild-Moderate CD). Methods Patients aged 6-25 years with mild-moderate CD were randomized to follow T&H or EEN for 8 weeks, receiving weekly dietary support. The caring physician was blinded to the allocation. Data on nutrition, clinical symptoms, and calprotectin were collected at baseline and bi-weekly. Tolerability was defined as discontinuation of the intervention or low adherence, judged by weekly interviews and 24-hour intake diary. Effectiveness outcomes included clinical remission (wPCDAI/CDAI), MINI index (<8 points reflecting mucosal healing), CRP, ESR, and calprotectin. Those not tolerating either intervention during the first 24 hours were excluded; otherwise, figures reflect intention to treat (ITT) results, unless per-protocol (PP) analyses is specified. Results A total of 83 patients were included (41 to T&H and 42 to EEN; mean age 14.5±3.7 years). The primary endpoint was met with 36 (88%) patients tolerating T&H vs. 22 (52%) tolerating EEN (OR 6.3 (95%CI 2.2-22; p<0.001). Clinical remission was achieved in 56% of the T&H arm and 38% of EEN (p=0.1; PP: 67% vs. 76%, respectively, p=0.47). MINI<8 at week 8 was higher in the T&H arm (54% vs. 41%; p=0.026) while there was no difference in the PP analysis. Calprotectin decreased significantly from baseline in both arms, without a difference across groups at week-8 (calprotectin <250 was noted in 38% with T&H vs 41% with EEN; p=0.84). Similarly, CRP and ESR decreased significantly in both groups (all p<0.05), with no between-group differences in either the ITT or PP analyses. There were 3 adverse events reported in this trial with at least possible association with the intervention, all mild, 2 in the EEN arm (nausea and dizziness) and 1 in the T&H arm (constipation). Conclusion The T&H diet showed comparable effectiveness to EEN for inducing clinical and biological remission in mild-moderate CD but had better tolerability. T&H offers a flexible alternative without the need for PEN.
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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 | 0.002 | 0.002 |
| Meta-epidemiology (narrow) | 0.001 | 0.000 |
| Meta-epidemiology (broad) | 0.003 | 0.003 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.001 |
| Scholarly communication | 0.001 | 0.001 |
| Open science | 0.001 | 0.000 |
| Research integrity | 0.002 | 0.002 |
| Insufficient payload (model declined to judge) | 0.006 | 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".