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DOP65 Dietary therapy with the Crohn’s Disease exclusion diet induces sustained clinical and endoscopic remission in adults with Mild to Moderate Crohn’s Disease: Results from the CDED-AD trial
- Source :
- Journal of Crohn's and Colitis. 15:S099-S100
- Publication Year :
- 2021
- Publisher :
- Oxford University Press (OUP), 2021.
-
Abstract
- Background Crohn’s disease exclusion diet (CDED) with partial enteral nutrition (PEN) is effective for induction of remission in children with mild-moderate Crohn’s disease (CD). Here we evaluated CDED in adults with CD. Methods This was an open-label prospective randomized controlled pilot trial in patients with mild-moderate CD defined as Harvey-Bradshaw Index (HBI) between 5–14, active disease on colonoscopy, or imaging with calprotectin>200 μ/gr. Group-I received CDED+PEN, and Group-II CDED-alone. A colonoscopy was performed at week-24. Endoscopic remission (ER) was defined as Simple Endoscopic Score for CD (SES-CD)≤3. The primary end-point was corticosteroid (CS) free remission defined as HBI Results Forty patients were included (median age 30 years [IQR;24–39], 19 patients- Group-I, 21 patients- Group-II). By intention-to-treat (ITT) analysis CS-free remission at week-6 was 62.5% of patients (25/40), comparable between Group-I 68.4%(13/19) vs.Group-II: 57.1%(12/21) (P=.46). Among remitters at week-6, sustained remission was present in 88%(22/25) week-12, and 80%(20/25) week-24. For patients with baseline elevated C-reactive protein (CRP) (n=30), median CRP decreased from 14.5 mg/L [IQR;7.7–37] to 8.4[IQR;5.4–18.5] at week6(P=.006), and to 8[IQR;5.4–20.6] week-24(P=.002). ER at week-24 was present in 14/28 patients (50%) and was 14/40(35%) by ITT. ER week-24 was similar between groups, 8/15(53.3%) vs. 6/13(46.1%) (P=.7). A comparison between baseline and week-24 SES-CD revealed a median of 5-points decrease (IQR; [-6.25]-[-1]), corresponding to 72.8% (IQR;20–100%) decline from baseline (P=.003). Conclusion CDED with or without PEN was effective for induction and maintenance of remission in adults with mild to moderate CD and may lead to endoscopic remission.
- Subjects :
- Crohn's disease
medicine.medical_specialty
Intention-to-treat analysis
medicine.diagnostic_test
business.industry
Surrogate endpoint
Gastroenterology
Colonoscopy
General Medicine
medicine.disease
Endoscopy
Parenteral nutrition
Elimination diet
Internal medicine
Endpoint Determination
Medicine
business
Subjects
Details
- ISSN :
- 18764479 and 18739946
- Volume :
- 15
- Database :
- OpenAIRE
- Journal :
- Journal of Crohn's and Colitis
- Accession number :
- edsair.doi...........9ea54424d3194b8ab9236fc333b30538