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Cyclic Exclusive Enteral Nutrition as Maintenance Therapy for Pediatric Crohn's Disease

NCT02201693 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-03-30

No results posted yet for this study

Summary

The purpose of this study is to compare the rate of first relapse at 12 months between maintenance therapy with cyclic exclusive enteral nutrition (EEN) (at least 100% daily calories) and maintenance therapy with supplementary enteral nutritional support (25% daily calories).

Conditions

Interventions

DIETARY_SUPPLEMENT

MODULEN IBD

2 week ON / 6 weeks OFF treatment every 8 weeks covering at least 100% of daily caloric requirement (approx. 2-2.5L/day).

DIETARY_SUPPLEMENT

MODULEN IBD

25% of daily caloric requirements, approx. 500mL/day

Sponsors & Collaborators

  • GETAID Pediatric

    collaborator OTHER

  • URC-CIC Paris Descartes Necker Cochin

    collaborator OTHER

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Franck RUEMMELE, MD, PhD · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2014-12-12
Primary Completion
2019-10-02
Completion
2019-10-02

Countries

  • France

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 NCT02201693 on ClinicalTrials.gov