NCT04160325

Brief Summary

for some patients with Crohn's diseases undergoing surgery，whether exclusive enteral nutrition(EEN) could delay the disease relapse needs exploration.The trial will study whether the efficacy of postoperative EEN could help keeping remission.

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
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2018

Longer than P75 for not_applicable

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, 2018

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2019

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 13, 2019

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

October 17, 2023

Status Verified

October 1, 2023

Enrollment Period

5.8 years

First QC Date

November 3, 2019

Last Update Submit

October 16, 2023

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

  • the 1 year postoperative anastomotic recurrence

    the 1 year postoperative anastomotic recurrence

    1 year

Study Arms (2)

3 months exclusive enteral nutrition plus azathioprine

EXPERIMENTAL

patients underwent surgery in this arm will given 3 months exclusive enteral nutrition,and free diet after 3 months. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.

Dietary Supplement: postoperative 3-month exclusive enteral nutritionDrug: azathioprine

normal diet plus azathioprine

ACTIVE COMPARATOR

patients underwent surgery in this arm will given free diet all through. All patients will be adminsrated with oral azathioprine to preventing disease recurrence.

Drug: azathioprineOther: normal diet

Interventions

postoperative 3-month exclusive enteral nutritionDIETARY_SUPPLEMENT

postoperative 3-month exclusive enteral nutrition after surgery and alter to normal food after 3 months

3 months exclusive enteral nutrition plus azathioprine
azathioprineDRUG

azathioprine

3 months exclusive enteral nutrition plus azathioprinenormal diet plus azathioprine
normal dietOTHER

normal diet

normal diet plus azathioprine

Eligibility Criteria

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

You may qualify if:

  • CD patients who undergoing bowel resection with anastomosis

You may not qualify if:

  • patients who had administered with immunomodulators or biological agents patients who were created stoma

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

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Interventions

Postoperative PeriodAzathioprine

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

Perioperative PeriodSurgical Procedures, OperativePatient CareHealth ServicesHealth Care Facilities Workforce and ServicesThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

weiming zhu

CONTACT

+86-025-80860036juwiming@nju.edu.cn

ming duan

CONTACT

+86-025-80860037duanming1206@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, Head of General Surgery, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

November 3, 2019

First Posted

November 13, 2019

Study Start

January 1, 2018

Primary Completion

October 31, 2023

Study Completion

October 31, 2023

Last Updated

October 17, 2023

Record last verified: 2023-10

Locations

CN(1)