Diet Intervention for Crohn's Disease Patient
Diet Intervention for Crohn's Disease Patient
The purpose of this study is to determine the effectiveness of a low-fat, high fiber diet
 (LFD) containing a minimal proportion of fat to improve gastrointestinal symptoms, quality of
 life and signs of inflammation in blood and stool.
Inclusion Criteria for Crohn's disease:

 -  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

 Exclusion Criteria for Crohn's disease:

 Patients with Ulcerative Colitis and Celiac Disease

 -  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

 -  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

 -  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

 -  Use of Total Parenteral Nutrition at the time of screening and during the study
 period.

 -  Presence of any of the following laboratory abnormalities during screening period or
 at least <12 weeks; Hemoglobin <8.0g/dl, Albumin <2.8g/dl.

 -  Uncooperative behavior or any condition that could make the patient potentially
 noncompliant to the study procedure

 -  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

 -  Known allergy to tree nuts or peanuts

 -  Pregnant women

 Inclusion and Exclusion Criteria for Family-like Member

 Inclusion:

 -  Male or Female ≥18 and ≤70 years old

 -  Live in the same household and be involved in the patients' daily diet

 -  No antibiotic use or probiotic use within 2 weeks prior to screening

 Exclusion Criteria

 -  Patients with Ulcerative Colitis and Celiac Disease

 -  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

 -  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

 -  Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus
 within 2 months prior to screening

 -  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

 -  Known allergy to tree nuts or peanuts

 -  Pregnant women