Diet Study on Ulcerative Colitis

Inclusion criteria

• Male or Female ≥18 and ≤70 years old
• History of UC of at least 3 months duration
• UC should be confirmed by colonoscopy within two years of entry into the study
• Patients with mild to moderate UC, or patients in remission that have had active disease within the past 18 months, regardless of treatment with mesalamines, immunosuppressants, anti-TNFs and/or vedolizumab

• Patients on oral 5-aminosalicylates, mesalamine or sulfasalazine must be on a stable dose for ≥2 weeks prior to screening
• Patients treated with anti-TNFs or immunosuppressants (AZA, 6-MP, or methotrexate) at screening must have been on a stable dose for ≥8 weeks and remain on the same dose during the treatment period
• Patients on steroids can be on no more than prednisone 20mg daily or budesonide 9mg daily at screening. If clinically indicated, tapering of steroids after 4 weeks of intervention may occur. Prednisone may be tapered by no more than 2.5mg/week and budesonide by no more than 3mg/week.
• Patients on infliximab, premedication may include intravenous corticosteroid
• No antibiotic use or probiotic use within 4 weeks prior to screening
• Signed written informed consent for enrollment into the study

Exclusion criteria

• Patients with Crohn's Disease and Celiac Disease
• History of colonic dysplasia except for adenoma on prior surveillance colonoscopy
• Patients with altered anatomy: prior colectomy or anticipated colectomy during the study period and presence of ileal pouch or ostomy
• Clinical manifestations concerning for fulminant disease or toxic megacolon
• Patients with stool sample positive at during screening period or at least <12 weeks for ova, parasites, or culture for aerobic pathogens including: Aeromonas, Plesiomonas, Shigella, Yersinia, Campylobacter and E.coli spp. or positive for Clostridium difficile B toxin in stools
• Use of cyclosporine, mycophenolate mofetil, sirolimus, thalidomide or tacrolimus within 2 months prior to screening
• Need for prednisone >20mg daily or budesonide >9mg 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
• Anti-diarrheal use within 2 weeks prior to screening
• Presence of any of the following laboratory abnormalities during screening period or at least <12 weeks

• Hemoglobin <8.0g/dl
• Albumin <2.8g/dl
• Conditions/situations such as:

• Patients with short life expectancy
• Uncooperative behavior or any condition that could make the patient potentially non-compliant to the study procedures
• Patients with pacemaker
• Other significant or life-threatening co-morbidities in which diet intervention could negatively affect
• Failure to meet any of the inclusion criteria
• Poor compliance with diet during the study period
• Failure to submit stool samples as indicated at each phase of the study
• The need for antibiotic use during the study period