Eligibility Details:
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
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
