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

NCT ID: NCT02056418

Last Updated: 2014-02-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-01-31

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.

Conditions

Crohn Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

enteral nutrition

The patients receive treatment of enteral nutrition only.

Group Type: EXPERIMENTAL

enteral nutrition

Intervention Type: DIETARY_SUPPLEMENT

enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)

Corticosteroid

The patients receive treatment of corticosteroid only.

Group Type: EXPERIMENTAL

corticosteroid

Intervention Type: DRUG

corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)

Healthy control

healthy people applied with normal diet.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

enteral nutrition

enteral nutrition only (Nutrison Fibre, 20-30kcal/kg/day)

Intervention Type: DIETARY_SUPPLEMENT

corticosteroid

corticosteroid(equal dose to prednisone 0.75mg/kg/day,4 weeks)

Intervention Type: DRUG

Other Intervention Names

prednisone; hydrocortisone

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jinling Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Zhu Weiming

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Countries

China

References

Guo D, Fang L, Liu R, Li Y, Lv L, Niu Z, Chen D, Zhou Y, Zhu W. Exploring Different Effects of Exclusive Enteral Nutrition (EEN) and Corticosteroids on the Gut Microbiome in Crohn's Disease Based on a Three-Stage Strategy. Gastroenterol Res Pract. 2022 Jul 27;2022:6147124. doi: 10.1155/2022/6147124. eCollection 2022.

Reference Type: DERIVED

PMID: 35935714 (View on PubMed)

Other Identifiers

ECDB-1

Identifier Type: -

Identifier Source: org_study_id