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

Study Description

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.

Study Design

• 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

Arms and Interventions

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Locations

China, Jiangsu

Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Nanjing, Jiangsu, China, 210002

Sponsors and Collaborators

Jinling Hospital, China

More Information

• Responsible Party: Zhu Weiming, professor, Jinling Hospital, China
• ClinicalTrials.gov Identifier: NCT02056418
• Other Study ID Numbers: ECDB-1
• First Posted: February 6, 2014
• Last Update Posted: February 6, 2014
• Last Verified: February 2014

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Prednisone; Hydrocortisone; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Antineoplastic Agents, Hormonal; Antineoplastic Agents