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

• Register: ClinicalTrials.gov
• Last refreshed on: 6 June 2022
• Main ID: NCT02843100
• Date of registration: 22/06/2016
• Prospective Registration: Yes
• Primary sponsor: Prof. Arie Levine
• Public title: Diet for Induction and Maintenance of Remission and Re-biosis in Crohn's Disease DIETOMICS-CD
• Scientific title: Modified Exclusive Enteral Nutrition With the Crohn's Disease Exclusion Diet for Induction and Maintenance of Remission and Re-biosis
• Date of first enrolment: April 10, 2018
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02843100
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Canada, Ireland, Israel, Spain

Contacts

• Name: Michal Yaakov
• Affiliation: Pediatric Gastroenterology and Nutrition unit; The E. Wolfson.Medical Center

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

Key inclusion & exclusion criteria

Inclusion criteria:

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 within the
past 3 weeks) 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

Exclusion Criteria:

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 Gangrenosum, Erythema Nodosum etc.)

5. Patients with complicated disease (B2, B3)

6. Patients who recently onset use of an immunomodulator <8 weeks, or dose change in past
8 weeks.

7. Patients with current use of biologics, or use in last 8 weeks or current use of
systemic steroids

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



Age minimum: 8 Years
Age maximum: 18 Years
Gender: All

Health Condition(s) or Problem(s) studied

Crohn's Disease

Intervention(s)

Other: Crohn's Disease Exclusion Diet

Other: Partial Enteral Nutrition

Other: Modified Exclusive Enteral Nutrition

Other: Standard Exclusive Enteral Nutrition

Primary Outcome(s)

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

Secondary Outcome(s)

Mucosal healing as assessed by MRE in dietary responsive disease at week 52 [Time Frame: Week 52]

Need for additional treatment to achieve remission by week 14 [Time Frame: Week 14]

3. Reduction of at least 50% from baseline in fecal calprotectin at week 24 for patients on original treatment [Time Frame: week 24]

ITT steroid free remission at week 8 [Time Frame: week 8]

Steroid and biologic free sustained remission at week 24. [Time Frame: week 14 and 24]

Microbiome composition difference between groups at week 14 [Time Frame: week 14]

Secondary ID(s)

0075-16 WOMC

Source(s) of Monetary Support

Please refer to primary and secondary sponsors