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Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease

NCT02843100 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 63

Last updated 2022-06-01

No results posted yet for this study

Summary

The modified-Exclusive Enteral Nutrition (mEEN) is an open label randomized controlled trial in mild to severe Crohn's Disease patients. The purpose of this study is to determine whether induction of remission and maintenance of remission can be achieved with a new dietary strategy that involves only 2 weeks of Exclusive Enteral Nutrition (EEN) with Modulen and 12 weeks of an exclusion diet involving selected table foods. This novel approach will be compared to the gold standard dietary regime involving 8 weeks of EEN.

Conditions

Interventions

OTHER

Modified Exclusive Enteral Nutrition

Two weeks of Exclusive Enteral Nutrition with Modulen

OTHER

Crohn's Disease Exclusion Diet

a limited whole food diet

OTHER

Partial Enteral Nutrition

25-50% of Energy from formula

OTHER

Standard Exclusive Enteral Nutrition

8 weeks of Exclusive Enteral Nutrition

Sponsors & Collaborators

  • Prof. Arie Levine

    lead OTHER_GOV

Principal Investigators

  • Rotem Sigall Boneh, RD · Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center

  • Michal Yaakov · Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-10
Primary Completion
2022-05-29
Completion
2022-05-29

Countries

  • Canada
  • Ireland
  • Israel
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02843100 on ClinicalTrials.gov