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

Primary Purpose

Crohn Disease

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

enteral nutrition

corticosteroid

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Patients should be in the age range of 18 - 75 years;
Patients should have clinical, imaging, endoscopic and histological diagnosis of CD based on WHO criteria
Patients should have a CDAI score of more than 150 and have a CRP level of more than 10mg/L at enrollment;
Patients will not be excluded if they have received 5-ASA(Aminosalicylic acid) or immunomodulator for >8 weeks and the dose is stable
Informed consent

Exclusion Criteria:

Patients who can't tolerate enteral nutrition because of complications, such as complete intestinal obstruction, gastrointestinal perforation or bleeding etc.
Patients who receive corticosteroids or enteral nutrition or prebiotics /probiotics/synbiotics/antibiotic treatment in the previous 4 weeks.
Patients who accompanied extra-intestinal manifestations, serve complications, and active perianal disease and need other drug therapies.
Patients who had ostomy or colectomy or subtotal colectomy
Patients with end-stage disease or is expected likely to die during the study
Patients are participating in other clinical trials or participated within 6 months prior to this study

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

enteral nutrition

Corticosteroid

Healthy control

Arm Description

The patients receive treatment of enteral nutrition only.

The patients receive treatment of corticosteroid only.

healthy people applied with normal diet.

Outcomes

Primary Outcome Measures

change of intestinal flora of stool

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

biochemical indexes

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)

Change from baseline of CDAI every week

Fecal Calcium Protein

Change from Baseline in Fecal Calcium Protein in every week

Full Information

NCT ID

NCT02056418

First Posted

January 24, 2014

Last Updated

February 4, 2014

Sponsor

Jinling Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02056418

Brief Title

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

Acronym

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 Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2014 (undefined)

Primary Completion Date

January 2016 (Anticipated)

Study Completion Date

January 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinling Hospital, China

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

enteral nutrition

Arm Type

Experimental

Arm Description

The patients receive treatment of enteral nutrition only.

Arm Title

Corticosteroid

Arm Type

Experimental

Arm Description

The patients receive treatment of corticosteroid only.

Arm Title

Healthy control

Arm Type

No Intervention

Arm Description

healthy people applied with normal diet.

Intervention Type

Dietary Supplement

Intervention Name(s)

enteral nutrition

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

corticosteroid

Other Intervention Name(s)

prednisone, hydrocortisone

Intervention Description

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

Primary Outcome Measure Information:

Title

change of intestinal flora of stool

Description

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

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

biochemical indexes

Description

Change from baseline of hematological and biochemical indexes (CRP(C-reactive protein), PCT(procalcitonin), ESR(erythrocyte sedimentation rate), Alb) of blood every week

Time Frame

6 weeks

Title

CDAI(Crohn's disease activity index)

Description

Change from baseline of CDAI every week

Time Frame

6 weeks

Title

Fecal Calcium Protein

Description

Change from Baseline in Fecal Calcium Protein in every week

Time Frame

6 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients should be in the age range of 18 - 75 years; Patients should have clinical, imaging, endoscopic and histological diagnosis of CD based on WHO criteria Patients should have a CDAI score of more than 150 and have a CRP level of more than 10mg/L at enrollment; Patients will not be excluded if they have received 5-ASA(Aminosalicylic acid) or immunomodulator for >8 weeks and the dose is stable Informed consent Exclusion Criteria: Patients who can't tolerate enteral nutrition because of complications, such as complete intestinal obstruction, gastrointestinal perforation or bleeding etc. Patients who receive corticosteroids or enteral nutrition or prebiotics /probiotics/synbiotics/antibiotic treatment in the previous 4 weeks. Patients who accompanied extra-intestinal manifestations, serve complications, and active perianal disease and need other drug therapies. Patients who had ostomy or colectomy or subtotal colectomy Patients with end-stage disease or is expected likely to die during the study Patients are participating in other clinical trials or participated within 6 months prior to this study

Facility Information:

Facility Name

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

City

Nanjing

State/Province

Jiangsu

ZIP/Postal Code

210002

Country

China

12. IPD Sharing Statement

Citations:

PubMed Identifier

35935714

Citation

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.

Results Reference

derived

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

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