P1059 Fecal calprotectin response to Tasty&Healthy dietary intervention in asymptomatic children and young adults with biologically active Crohn’s disease: results of the “TASTI-E” randomized controlled trial
Bibliographic record
Abstract
Abstract Background Tasty&HealthyTM (T&H) is a whole food diet aimed at alleviating inflammation in Crohn’s disease (CD). It excludes processed food, gluten, red meat, and dairy (except for plain yogurt), but does not include mandatory ingredients or partial enteral nutrition with formula as does the CD Exclusion Diet. In this RCT we evaluated T&H diet as an intervention for persistent subclinical inflammation compared with continuing habitual diet. (NCT#04239248; TASTI-E). Methods Patients with CD, aged 6-40 years, in clinical remission or with minimal symptoms (wPCDAI<20/CDAI<200), were randomized if their MINI-index was ≥8 (i.e. bowel inflammation), to receiving either T&H or continuing their habitual diet for 8 weeks. Patients in the latter group were also offered T&H after completing the initial 8 week randomization period. The primary outcome was calprotectin-defined response (i.e. reduction of >50%). Secondary outcomes included adherence, MINI-index, and CRP. Due to COVID-19-related slow enrolment, the study was terminated early, and thus analyses are exploratory on a per-protocol basis. Results 46 patients were randomized (mean age 18.2±7.6 years; median disease duration 9.01 months, IQR 2.9-17.1); 19 were assigned to T&H and 27 to the habitual group. The primary endpoint was achieved, with 7 patients (37%) in the T&H group achieving calprotectin response, vs 4 (15%) in the habitual group (RR 3.23 [95% CI 1.15-9.01]; p=0.028). A pre-post comparison of 15 patients who completed 8 weeks of habitual diet and crossed-over to T&H, showed higher rates of calprotectin<250 mcg/g at week 16 compared with their baseline at week 8 (47% vs. 17%, p=0.005) and MINI<8 (60% vs 20%, p=0.0013). Additionally, compared with the habitual diet, the improvement in CRP 0.48 (0.18-0.81) vs. 0.36 (0.1-0.36); p=0.0012) and MINI (10 (9-13) vs. 7 (5-10.5); p=0.047) was higher in the T&H arm, respectively. The absence of gluten levels in stool was used as a measure of adherence to the T&H diet. At week 8, only 2/13 patients (15%) in the T&H group tested positive for stool gluten, compared to 18/20 patients (90%) in the habitual diet group (p=0.002), demonstrating high adherence to T&H. Patients in the T&H arm met over 95% of Dietary Reference Intakes (DRI) for key macro- and micronutrients. No significant differences were found between the groups except for higher potassium and fiber in the T&H group (p=0.018 and p<0.001, respectively). Conclusion The T&H diet is effective in reducing inflammation in children and adults with CD who have subclinical inflammation. The flexibility of T&H without the need for formula feeds or mandatory ingredients is associated with high adherence.
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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) | 0.001 | 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) | 0.005 | 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".