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

Crohn Disease Clinical Trial

— EN  

Official title:

A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02056418
• Other study ID #: ECDB-1
• Status: Active, not recruiting
• Phase: Phase 4
• First received: January 24, 2014
• Last updated: February 4, 2014
• Start date: January 2014
• Est. completion date: January 2016

Study information

• Verified date: February 2014
• Source: Jinling Hospital, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Dietary Supplement:
• enteral nutrition
enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)

Drug:
• corticosteroid
corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)

Locations

Country	Name	City	State
China	Department of General Surgery, Jinling hosptal,Medical School of Nanjing University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Jinling Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	6 weeks	No
Secondary	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	6 weeks	No
Secondary	CDAI(Crohn's disease activity index)	Change from baseline of CDAI every week	6 weeks	No
Secondary	Fecal Calcium Protein	Change from Baseline in Fecal Calcium Protein in every week	6 weeks	No