NCT02056418

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

January 24, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

2 years

First QC Date

January 24, 2014

Last Update Submit

February 4, 2014

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • biochemical indexes

    6 weeks

  • CDAI(Crohn's disease activity index)

    6 weeks

  • Fecal Calcium Protein

    6 weeks

Study Arms (3)

enteral nutrition

EXPERIMENTAL

The patients receive treatment of enteral nutrition only.

Dietary Supplement: enteral nutrition

Corticosteroid

EXPERIMENTAL

The patients receive treatment of corticosteroid only.

Drug: corticosteroid

Healthy control

NO INTERVENTION

healthy people applied with normal diet.

Interventions

enteral nutritionDIETARY_SUPPLEMENT

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

enteral nutrition
corticosteroidDRUG

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

Also known as: prednisone, hydrocortisone
Corticosteroid

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210002, China

Location

Related Publications (1)

  • 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.

    PMID: 35935714DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

Enteral NutritionAdrenal Cortex HormonesPrednisoneHydrocortisone

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition TherapyHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnenedionesPregnenes11-HydroxycorticosteroidsHydroxycorticosteroids17-Hydroxycorticosteroids

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

January 24, 2014

First Posted

February 6, 2014

Study Start

January 1, 2014

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

CN(1)