Diet Intervention for Crohn's Disease Patient

Korábbi kezelés

• Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
• Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
• Need for prednisone \> 20 mg daily or budesonide \> 9 mg daily at the time of screening. Received intravenous corticosteroids within 2 weeks prior to screening, during screening, or during the study period except as premedication for anti-TNFs
• No antibiotic use or probiotic use within 2 weeks prior to screening
• Abdominal abscess, symptomatic Intestinal stricture, patients with altered anatomy: prior total colectomy or proctocolectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
• Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening

Más betegség

• Patients with Ulcerative Colitis and Celiac Disease
• Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedure
• Known allergy to tree nuts or peanuts
• Patients with Ulcerative Colitis and Celiac Disease
• Known allergy to tree nuts or peanuts

Laborértékek

• Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such as Patients with short life expectancy
• Presence of any of the following laboratory abnormalities during screening period or at least \<12 weeks; Hemoglobin \<8.0g/dl, Albumin \<2.8g/dl.
• Other clinically meaningful laboratory abnormalities: pregnancy or lactation, an unstable or uncontrolled medical disorder, colonic dysplasia or adenomas, and malignant neoplasms. Toxic megacolon situations such Uncooperative behavior or any condition that could make the patient potentially noncompliant to the study procedures. Patients with short life expectancy

Életkor

• Male or Female ≥18 and ≤70 years old

Egyéb

• Use of Total Parenteral Nutrition at the time of screening and during the study period.
• Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
• The need for antibiotic use during the study period
• Pregnant women
  • Inclusion and Exclusion Criteria for Family-like Member
  • Inclusion:
• Live in the same household and be involved in the patients' daily diet
• Use of Total Parenteral Nutrition at the time of screening and during the study period.
• Other significant or life-threatening co-morbidities in which low fat/high fiber diet intervention could negatively affect
• The need for antibiotic use during the study period
• Pregnant women

• Male or Female ≥18 and ≤70 years old and lives with someone that is involved in daily diet
• Documented diagnosed of Crohn's Disease
• sCDAI less than 400
• Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
• Treated with anti-Tumor Necrotic Factors (TNFs) or immunosuppressants (AZA, 6-Mercaptopurine (6-MP), or methotrexate) at screening must have been on a stable dose for ≥4 weeks
• On steroids can be on no more than prednisone 20 mg daily or budesonide 9 mg daily at the screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/wk and budesonide by no more than 3 mg/wk.
• No antibiotic use or probiotic use within 2 weeks prior to screening