Modified Exclusive Enteral Nutrition with the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis

Recruitment & Eligibility

Status: Withdrawn

Sex: Not specified

Target Recruitment: 35

Inclusion Criteria

For Patients
1. Established diagnosis of Crohn's disease.
2. Patients with mild to severe active Crohn's disease (15*PCDAI*47.5)
3. Ages 8-18
4. Duration of disease * 36 months
5. Active inflammation (CRP*0.6 mg/dL or ESR*20 or Calprotectin*200 mcg/gr
during screening
6. Patients with B1, P0 uncomplicated disease at enrollment
7. 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)
8. Signed informed consent

Inclusion criteria comments:
1. Patients with stable medication (IMM/5ASA) use or no medication use for the
past 8 weeks may be enrolled.
2. Patients with few aphthous ulcers in the rectosigmoid only can be enrolled
as L2

Exclusion Criteria

For patients
1. Patients with very mild disease (PCDAI 12.5-15) or very severe disease
(PCDAI >47.5)
2. Pregnancy
3. Patients who have disease confined to the colon involving the descending
colon, rectum or sigmoid colon and no prior history of small bowel involvement
4. Patients who have active extra intestinal disease (such as arthritis,
uveitis, pyoderma gangresom, erythema nodosum, etc.)
5. Patients with complicated disease (B2, B3)
6. Patients with recent onset use of an immunomodulator <8 weeks, or dose
change in past 8 weeks.
7. Patients with past or current use of biologics, or patients who currently
use systemic steroids or used steroids over the last 8 weeks
8. Patients who have active perianal disease (active fistula or abscess)
9. Patients who have positive stool cultures with relevant pathogens, or
positive tests for parasites or C. difficile. Stool tests are mandatory only if
diarrhea is present.
10. Patients with fever > 38.3
11. Documented milk protein allergy

Exclusion criteria comments:
1. Aphthous stomatitis is not an exclusion criterion. Isolated aphthous ulcers
of the rectosigmoid need not be excluded as left sided L2 only
2. Patient may receive a stable dose immunomodulator or start thiopurines at or
after week 4 or Methotrexate at week 6, since the effect of thiopurine starts
after 8 weeks and that does not affect the primary endpoint remission at week 8.
3. Patients are allowed use of Omeprazole if ulcers or erosions are present in
the stomach or duodenum.
4. Patients may receive antibiotics for intercurrent infections for up to 10
days with the exception of quinolones, metronidazole, rifaximin or oral
vancomycin; antibiotics used must be registered in the CRF.
5. Patients with skin tags or fissures can be enrolled.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p> ITT, sustained Corticosteroid-free remission at week 14 (defined as Pediatric<br /><br>Crohn Disease Activity Index- PCDAI *10 without exposure to systemic steroids).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1. ITT steroid-free clinical remission at week 8<br /><br>2. Microbiome composition difference between groups at week 14<br /><br>3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for<br /><br>patients who did not change their treatment<br /><br>4. Steroid and biologic free remission at week 24.<br /><br>5. Need for additional treatment to achieve remission by week 14<br /><br>6. Transmural healing as assessed by MRE in dietary responsive disease at week<br /><br>52<br /><br>7. The proportion of patients who respond with the susceptible genes compare to<br /><br>those without the susceptible genes<br /><br>8. Microbiome composition difference between dietary responders to healthy<br /><br>controls at week 24</p><br>