Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease

PHASE3RecruitingINTERVENTIONAL
Enrollment

256

Participants

Timeline

Start Date

March 1, 2021

Primary Completion Date

January 1, 2026

Study Completion Date

January 1, 2026

Conditions
Crohn DiseaseNutrient; ExcessRemission/Regression
Interventions
DIETARY_SUPPLEMENT

EEN (Nestle Modulen®)

35kcal/kg/day for every patient

DRUG

Standart of care

"* Budesonide 9mg/day for mild disease~* Prednisolone 1mg/kg, maximum 40mg/day in decreasing doses (40mg for 4 weeks followed by a fixed taper for 6 weeks) for moderate-to-severe disease for 12 weeks.~* Patients with moderate to severe disease in the steroid group will also receive 2mg/kg azathioprine. The dose of azathioprine will be adjusted according to abnormalities of white blood cell (WBC) count, platelet count, liver function tests (LFTs; i.e. alanine transaminase \[ALT\], aspartate transaminase \[AST\], alkaline phosphatase), lipase, blood urea nitrogen (BUN), and serum creatinine."

Trial Locations (1)

81620

RECRUITING

Duzce University School of Medicine, Düzce

All Listed Sponsors
lead

Duzce University

OTHER

NCT04921033 - Exclusive Enteral Nutrition in Patients With Ileocaecal Crohn's Disease | Biotech Hunter | Biotech Hunter