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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

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.

Condition or disease Intervention/treatment Phase
Crohn Disease Dietary Supplement: enteral nutrition Drug: corticosteroid Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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
Study Start Date : January 2014
Estimated Primary Completion Date : January 2016
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Prednisone

Arm Intervention/treatment
Experimental: enteral nutrition
The patients receive treatment of enteral nutrition only.
Dietary Supplement: enteral nutrition
enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)

Experimental: Corticosteroid
The patients receive treatment of corticosteroid only.
Drug: corticosteroid
corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)
Other Names:
  • prednisone
  • hydrocortisone

No Intervention: Healthy control
healthy people applied with normal diet.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. CDAI(Crohn's disease activity index) [ Time Frame: 6 weeks ]
    Change from baseline of CDAI every week

  3. Fecal Calcium Protein [ Time Frame: 6 weeks ]
    Change from Baseline in Fecal Calcium Protein in every week



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02056418


Locations
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China, Jiangsu
Department of General Surgery, Jinling hosptal,Medical School of Nanjing University
Nanjing, Jiangsu, China, 210002
Sponsors and Collaborators
Jinling Hospital, China

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Responsible Party: Zhu Weiming, professor, Jinling Hospital, China
ClinicalTrials.gov Identifier: NCT02056418    
Other Study ID Numbers: ECDB-1
First Posted: February 6, 2014    Key Record Dates
Last Update Posted: February 6, 2014
Last Verified: February 2014
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Prednisone
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents