Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Miami
With
The Leona M. and Harry B. Helmsley Charitable Trust
Age
18–70
Sex
ALL
Healthy volunteers
Accepted
You may be eligible if
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
You may not be if
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:
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
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
Clareo Health | Diet Intervention for Crohn's Disease Patient
