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

A Randomized, Controlled, Single-blind Study of Effects of Enteral Nutrition and Corticosteroid on Intestinal Flora in Induction Remission of Crohn Disease in Adult

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease
• Intervention / Treatment: Dietary supplement: enteral nutrition; Drug: corticosteroid

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: Interventional
• Enrollment (Anticipated): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • Department of General Surgery, Jinling hosptal,Medical School of Nanjing University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / 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: hydrocortisone; prednisone
No Intervention: Healthy control; healthy people applied with normal diet.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	6 weeks
CDAI(Crohn's disease activity index)	Change from baseline of CDAI every week	6 weeks
Fecal Calcium Protein	Change from Baseline in Fecal Calcium Protein in every week	6 weeks

Collaborators and Investigators

• Sponsor: Jinling Hospital, China

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2016

Study Registration Dates

• First Submitted: January 24, 2014
• First Submitted That Met QC Criteria: February 4, 2014
• First Posted (Estimate): February 6, 2014

Study Record Updates

• Last Update Posted (Estimate): February 6, 2014
• Last Update Submitted That Met QC Criteria: February 4, 2014
• Last Verified: February 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Prednisone; Hydrocortisone
• Other Study ID Numbers: ECDB-1