The pathogenesis of Crohn Disease (CD) is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, Enteral nutrition (EN) is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
The pathogenesis of CD is unknown, but there is evidence show that the inadequate immune response or overreaction of the immune system against food antigens or components of the commensal flora involve it. Corticosteroid therapy is effective for adult patients with CD, but it has side effects and can't promote mucosal healing. In recent years, EN is becoming primary therapy in induction and maintenance remission of CD, especially in children. But the mechanism of EN in induction and maintenance remission of CD is still unclear, and parts of patient have good clinical response to EN therapy while other don't. So we design the study to explore whether EN treats CD by effecting intestinal flora and whether the intestinal flora of patient with CD relates with clinical response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)
corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, China
change of intestinal flora of stool
Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention
Time frame: 6 weeks
biochemical indexes
Change from baseline of hematological and biochemical indexes (CRP(C-reactive protein), PCT(procalcitonin), ESR(erythrocyte sedimentation rate), Alb) of blood every week
Time frame: 6 weeks
CDAI(Crohn's disease activity index)
Change from baseline of CDAI every week
Time frame: 6 weeks
Fecal Calcium Protein
Change from Baseline in Fecal Calcium Protein in every week
Time frame: 6 weeks
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