Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult

Phase 4

• Conditions: Crohn Disease
• Interventions: Drug: corticosteroid; Dietary Supplement: enteral nutrition

• Registration Number: NCT02056418
• Lead Sponsor: Jinling Hospital, China

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-24
• Status Verified: 2014-02
• Study First Submitted QC: 2014-02-04
• Last Update Submitted: 2014-02-04
• Study First Posted: 2014-02-06
• Last Update Posted: 2014-02-06
• Primary Completion: 2016-01
• Study Completion: 2016-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Patients should be in the age range of 18 - 75 years;
2. Patients should have clinical, imaging, endoscopic and histological diagnosis of CD based on WHO criteria
3. Patients should have a CDAI score of more than 150 and have a CRP level of more than 10mg/L at enrollment;
4. Patients will not be excluded if they have received 5-ASA(Aminosalicylic acid) or immunomodulator for >8 weeks and the dose is stable
5. Informed consent

Exclusion Criteria

1. Patients who can't tolerate enteral nutrition because of complications, such as complete intestinal obstruction, gastrointestinal perforation or bleeding etc.
2. Patients who receive corticosteroids or enteral nutrition or prebiotics /probiotics/synbiotics/antibiotic treatment in the previous 4 weeks.
3. Patients who accompanied extra-intestinal manifestations, serve complications, and active perianal disease and need other drug therapies.
4. Patients who had ostomy or colectomy or subtotal colectomy
5. Patients with end-stage disease or is expected likely to die during the study
6. Patients are participating in other clinical trials or participated within 6 months prior to this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid	corticosteroid	The patients receive treatment of corticosteroid only.
enteral nutrition	enteral nutrition	The patients receive treatment of enteral nutrition only.

Primary Outcome Measures

Name	Time	Method
change of intestinal flora of stool	6 weeks	Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention

Secondary Outcome Measures

Name	Time	Method
CDAI(Crohn's disease activity index)	6 weeks	Change from baseline of CDAI every week
Fecal Calcium Protein	6 weeks	Change from Baseline in Fecal Calcium Protein in every week
biochemical indexes	6 weeks	Change from baseline of hematological and biochemical indexes (CRP(C-reactive protein), PCT(procalcitonin), ESR(erythrocyte sedimentation rate), Alb) of blood every week

Trial Locations

Locations (1)

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University; 🇨🇳 Nanjing, Jiangsu, China