CDED plus PEN vs EENCD · Other
Crohn's Disease Exclusion Diet Plus Partial Enteral Nutrition Induces Sustained Remission in a Randomized Controlled Trial
Levine A, et al.
Gastroenterology 2019 · PMID 31170412 (PubMed, opens in a new tab) · doi 10.1053/j.gastro.2019.04.021 (full paper, opens in a new tab)
| Endpoint | CDED + PEN | EEN | Difference |
|---|---|---|---|
| Tolerated the diet (primary endpoint) | 97.5% (39/40) | 73.6% (28/38) | P=0.002; odds ratio 13.92 (95% CI 1.68–115.14) |
| Corticosteroid-free remission, Week 6 | 75% (30/40) | 59% (20/34) | P=0.38 |
| Sustained corticosteroid-free remission, Week 12 | 75.6% (28/37) | 45.1% (14/31) | P=0.01; odds ratio 3.77 (95% CI 1.34–10.59) |
Week-6 remission did not differ significantly; the week-12 gap came after the EEN group returned to a free diet.
Source: Levine 2019, abstract. Four children withdrew for intolerance within 48 hours and were left out of the remission analysis, so remission denominators are smaller.
Structured abstract
BackgroundExclusive enteral nutrition induces remission in children with Crohn's disease but is hard to sustain; a whole-food exclusion diet with partial formula might be easier to follow.
MethodsProspective randomised controlled trial, 12 weeks. 78 patients. Primary endpoint: Dietary tolerance.
ResultsPrimary result. Tolerated by 97.5% (39/40) with CDED plus PEN vs 73.6% (28/38) with EEN; P=0.002; OR 13.92 (95% CI 1.68–115.14).
Take-homeIn children with mild to moderate Crohn's disease, CDED plus partial enteral nutrition is better tolerated than exclusive enteral nutrition and gives more sustained remission at 12 weeks.
| Patients | 78 |
|---|---|
| Population | Children with mild to moderate Crohn's disease; 74 included in the remission analysis (mean age 14.2 years). |
| Comparison | CDED plus partial enteral nutrition vs exclusive enteral nutrition |
| Drugs | Crohn's disease exclusion diet, partial enteral nutrition (Modulen), exclusive enteral nutrition |
| Classes | Diet therapy |
| Published | Levine A, et al. Gastroenterology 2019;157:440–50. |
Key points
- CDED arm: 50% of calories from formula (Modulen) for 6 weeks, then 25% to week 12. EEN arm: EEN for 6 weeks, then free diet plus 25% partial enteral nutrition.
- Corticosteroid-free remission (PCDAI below 10) at week 6: 75% (30/40) CDED plus PEN vs 59% (20/34) EEN; P=0.38.
- Sustained corticosteroid-free remission at week 12: 75.6% (28/37) vs 45.1% (14/31); P=0.01; OR 3.77 (95% CI 1.34–10.59).
- Remission on CDED plus PEN was associated with lower CRP and faecal calprotectin and fewer faecal Proteobacteria.
- In adults, the open-label pilot CDED-AD trial reported week 6 clinical remission of 68% with CDED plus PEN and 57% with CDED alone (P=0.4618) (PMID 34739863).
Limitations
- Open-label dietary trial; primary endpoint was tolerance, and remission outcomes were secondary.
- Mild to moderate paediatric disease only; small numbers.
- The comparator arm returned to a free diet after week 6, which favours CDED for sustained remission.
Commentary
This trial made the Crohn’s disease exclusion diet a practical alternative to exclusive enteral nutrition for inducing remission in children. Dietitian support is essential. Evidence in adults is limited to smaller trials such as CDED-AD; diet is generally used as an adjunct rather than a replacement for advanced therapy in moderate to severe adult disease.
Journal club
Design
Prospective randomised controlled trial, 12 weeks. 78 patients.
Primary result. Tolerated by 97.5% (39/40) with CDED plus PEN vs 73.6% (28/38) with EEN; P=0.002; OR 13.92 (95% CI 1.68–115.14).
Validity and applicability
- Open-label dietary trial; primary endpoint was tolerance, and remission outcomes were secondary.
- Mild to moderate paediatric disease only; small numbers.
- The comparator arm returned to a free diet after week 6, which favours CDED for sustained remission.
Where it sits now
In children with mild to moderate Crohn's disease, CDED plus partial enteral nutrition is better tolerated than exclusive enteral nutrition and gives more sustained remission at 12 weeks.
Questions for discussion
- The primary endpoint was tolerance, and remission was secondary. How much weight should the week-12 remission difference carry?
- After week 6 the comparator group returned to a free diet. Is the week-12 comparison a test of CDED, or of continuing any dietary therapy?
- How would you use CDED in an adult with moderate ileal Crohn's disease, and what support would you arrange?