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

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ClinicalTrials.gov Identifier: NCT02056418
Recruitment Status : Unknown
Verified February 2014 by Zhu Weiming, Jinling Hospital, China.
Recruitment status was:  Active, not recruiting
First Posted : February 6, 2014
Last Update Posted : February 6, 2014
Sponsor:
Information provided by (Responsible Party):
Zhu Weiming, Jinling Hospital, China

Tracking Information
First Submitted Date  ICMJE January 24, 2014
First Posted Date  ICMJE February 6, 2014
Last Update Posted Date February 6, 2014
Study Start Date  ICMJE January 2014
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: February 4, 2014)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2016
Estimated Primary Completion Date January 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02056418
Other Study ID Numbers  ICMJE ECDB-1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Zhu Weiming, Jinling Hospital, China
Study Sponsor  ICMJE Jinling Hospital, China
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Jinling Hospital, China
Verification Date February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP