Overview

This trial is active, not recruiting.

Condition crohn disease
Treatments enteral nutrition, corticosteroid
Phase phase 4
Sponsor Jinling Hospital, China
Start date January 2014
End date January 2016
Trial size 30 participants
Trial identifier NCT02056418, ECDB-1

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Experimental)
The patients receive treatment of enteral nutrition only.
enteral nutrition
enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)
(Experimental)
The patients receive treatment of corticosteroid only.
corticosteroid prednisone
corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)
(No Intervention)
healthy people applied with normal diet.

Primary Outcomes

Measure
change of intestinal flora of stool
time frame: 6 weeks

Secondary Outcomes

Measure
biochemical indexes
time frame: 6 weeks
CDAI(Crohn's disease activity index)
time frame: 6 weeks
Fecal Calcium Protein
time frame: 6 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

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
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by Jinling Hospital, China.