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

• ClinicalTrials.gov Identifier: NCT02056418
• Recruitment Status: Unknown
• First Posted: February 6, 2014
• Last Update Posted: February 6, 2014
• Sponsor: Jinling Hospital, China
• Information provided by (Responsible Party): Zhu Weiming, Jinling Hospital, China

Tracking Information

• First Submitted Date: January 24, 2014
• First Posted Date: February 6, 2014
• Last Update Posted Date: February 6, 2014
• Study Start Date: January 2014
• Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 4, 2014)

change of intestinal flora of stool [ Time Frame: 6 weeks ]

Change from baseline in diversity and composition of intestinal flora of stool every week and time point of clinical remission after intervention

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 4, 2014)

• biochemical indexes [ Time Frame: 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
• CDAI(Crohn's disease activity index) [ Time Frame: 6 weeks ]
  Change from baseline of CDAI every week
• Fecal Calcium Protein [ Time Frame: 6 weeks ]
  Change from Baseline in Fecal Calcium Protein in every week

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult
• 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
• 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 Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: 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)
  Other Names:

  • prednisone
  • hydrocortisone

Study Arms

• Experimental: enteral nutrition
  The patients receive treatment of enteral nutrition only.
  Intervention: Dietary Supplement: enteral nutrition
• Experimental: Corticosteroid
  The patients receive treatment of corticosteroid only.
  Intervention: Drug: corticosteroid
• No Intervention: Healthy control
  healthy people applied with normal diet.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: February 4, 2014): 30
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 2016
• Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT02056418
• Other Study ID Numbers: ECDB-1
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Zhu Weiming, Jinling Hospital, China
• Study Sponsor: Jinling Hospital, China
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Jinling Hospital, China
• Verification Date: February 2014