NCT02201693

Brief 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

July 17, 2014

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 28, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

December 12, 2014

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2019

Completed
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.8 years

First QC Date

July 17, 2014

Last Update Submit

March 25, 2026

Conditions

Crohn's Disease

Keywords

Crohn's disease,pediatric GETAID (Therapeutic study group of inflammatory bowel diseases of the child),enteral nutrition,randomized multicenter study

Outcome Measures

Primary Outcomes (1)

  • The first relapse

    Assessed with wPCDAI

    12 months

Secondary Outcomes (8)

  • Clinical remission

    12 months

  • Time to the first relapse

    until month 12

  • Variation of wPCDAI,

    until month12

  • Endoscopic remission

    month 12

  • Transmural healing

    Month 12

  • +3 more secondary outcomes

Study Arms (2)

Cyclic exclusive MODULEN IBD

EXPERIMENTAL

Cyclic exclusive MODULEN IBD for 2 weeks every 8 weeks

Dietary Supplement: MODULEN IBD

MODULEN IBD supplementation (25% of caloric requirements)

EXPERIMENTAL

MODULEN IBD supplementation (25% of caloric requirements) alone A Physician not involved in the study design and blinded to the treatment arm will perform the evaluation of the patients during each study visit.

Dietary Supplement: MODULEN IBD

Interventions

MODULEN IBDDIETARY_SUPPLEMENT

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

Cyclic exclusive MODULEN IBD

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • years
  • Confirmed Crohn's disease (L1, L2, L3+/- L4a/b)
  • new-onset disease or acute relapse treated with enteral nutrition
  • completed cycle of induction therapy of at least 6 weeks (6-12 weeks)
  • ASA and derivates have to be stopped at least at screening visit
  • Informed and signed consent

You may not qualify if:

  • Patients with B2 or B3 disease behavior (intestinal/colonic stenosis (including ileo-caecal valve), intrabdominal abscess, fistulizing disease)
  • Patients not in remission on induction therapy (wPCDAI\>12.5)
  • Patients with isolated and severe perianal disease
  • Ongoing steroid medication
  • Ongoing immunosuppressor or biologics therapy
  • No informed consent
  • Currently participating or having participated in another interventional clinical trial during the last 4 weeks prior to the beginning of this study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Necker - Enfants Malades

Paris, 75015, France

Location

Related Publications (1)

  • Pigneur B, Martinez-Vinson C, Bourmaud A, Dabadie A, Duclaux-Loras R, Hugot JP, Roman C, Dumant C, Spyckerelle C, Guinard-Samuel V, Willot S, Dupont C, Breton A, Caron N, Chaillou E, Rebouissoux L, Bertrand V, Triolo V, Pages J, Djeddi D, Bonneton M, Uhlen S, Catteau N, Coopman S, Lepage P, Viala J, Ruemmele FM. Cyclic exclusive enteral nutrition versus partial enteral nutrition to maintain long-term drug-free remission in paediatric Crohn's disease (CD-HOPE): an open-label, endpoint-blinded, randomised controlled trial. Lancet Gastroenterol Hepatol. 2026 Mar;11(3):204-217. doi: 10.1016/S2468-1253(25)00262-6. Epub 2026 Jan 19.

    PMID: 41570843DERIVED

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Franck RUEMMELE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2014

First Posted

July 28, 2014

Study Start

December 12, 2014

Primary Completion

October 2, 2019

Study Completion

October 2, 2019

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)