"Tasty&Healthy" Dietary Approach for Crohn's Disease

Prior treatment

• Prior failure of exclusive enteral nutrition or any other dietary intervention, for any reason.
• The use of steroids or budesonide in the recent month, or antibiotics prescribed to treat the CD in the previous two weeks.
• Prior intestinal resection.
• For ACTIVE-RCT-I: any prior or concurrent biologic therapy; for MH-RCT-II: any prior or concurrent biologic therapy other than second line biologic

Other illness

• Fistulizing perianal disease which is not in complete remission.
• Celiac disease.

Other

• Fibrostenotic or penetrating phenotype.
• "Ulcerative colitis (UC)-like" isolated Crohn's colitis.
• Any formula feed during the last month.
• Pregnancy.

• ACTIVE-RCT-I
• Children and young adults aged 6-24 years with established diagnosis of CD by European crohn's and colitis organisation (ECCO) /The European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN) criteria.
• \<1 years of disease duration since the time of CD diagnosis.
• Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
• Mild- moderate disease activity (wPCDAI 20-57.5 or CDAI 200-45) or milder disease (wPCDAI 12.5-57.5 or CDAI 150-450) that according to the physician's discretion warrants an immediate change in treatment (and thus cannot be included in the MH-RCT-II that has a non-treatment arm).
• Currently receiving no drug treatment or on maintenance treatment with immunomodulators (at stable dose for at least 16 weeks) or 5-aminosalicylic acid (5ASA)/sulfasalazine (at stable dose for at least 8 weeks). No current or prior treatment with biologics is allowed (i.e. biologic-naïve).
  • MH-RCT-II
• Children and young adults aged 6-40 years with established diagnosis of CD by ECCO/ESPGHAN criteria.
• \<1 years of disease duration since the time of CD diagnosis, or \<3 years of disease duration since the time of CD diagnosis for patients without evidence of significant bowel wall thickening (≤4 mm) without any damage as much as known.
• Willingness to provide stool samples during the visits, at baseline, week 4 and week 8.
• MINI ≥8 points.
• Clinical remission or at most minimal symptoms (wPCDAI\<20/ CDAI\<200) that according to the physician's discretion do not warrant immediate medical treatment.
• Receiving no treatment or on maintenance treatment with immunomodulators and/or first biologic (both at stable dose and interval for at least 16 weeks), and/or 5ASA/sulfasalazine (at stable dose for at least 8 weeks).
  • Second line biologics are allowed for patients without evidence of significant bowel wall thickening (≤4 mm) without bowel damage as much as known.