CompletedNot Applicable

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

Canada, Ireland, Israel63 participantsStarted 2018-04-10

Plain-language 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.

Who can participate

Age range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Established diagnosis of Crohn's disease.
. Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
. Ages 8-18
. Duration of disease ≤ 36 months
. Active inflammation (CRP≥\>0.6 mg /dL or ESR≥\>20 or Calprotectin≥\>200 mcg/gr within the past 3 weeks) during screening
. Patients with B1, P0 uncomplicated disease at enrollment
. Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with left sided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

ITT, steroid free Clinical remission (defined as Pediatric Crohn's Disease Activity Index (PCDAI)<10) at week 14

Timeframe: week 14

Trial details

NCT IDNCT02843100

SponsorProf. Arie Levine

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2022-05-29

View on ClinicalTrials.gov More Crohn's Disease trials

Plain-language summary

Who can participate

Age range

8 Years – 18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Established diagnosis of Crohn's disease.
. Patients with mild to severe active Crohn's disease (15≤PCDAI≤47.5)
. Ages 8-18
. Duration of disease ≤ 36 months
. Active inflammation (CRP≥\>0.6 mg /dL or ESR≥\>20 or Calprotectin≥\>200 mcg/gr within the past 3 weeks) during screening
. Patients with B1, P0 uncomplicated disease at enrollment
. Patients with disease defined as L1, L4, L3 or L2 limited to cecum, ascending or transverse colon or L2 with left sided disease with terminal ileum or small bowel involvement in the past by the Paris classification (patients with macroscopic disease)

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

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

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria