Combination of Diet and Oral Budesonide for Ulcerative Colitis

Launched by WOLFSON MEDICAL CENTER · Mar 16, 2023

Keywords

ClinConnect Summary

The ReDUCE Trial is a study exploring the effects of a special diet combined with a medication called budesonide for patients with mild to moderate Ulcerative Colitis (UC). This trial aims to see if following an Ulcerative Colitis Exclusion Diet—along with specific nutritional support—can help improve symptoms and promote healing in the intestines. The researchers believe that this combination may positively change the gut bacteria, which could lead to better health outcomes for patients.

To be eligible for the trial, participants should be between 17 and 65 years old, have a confirmed diagnosis of mild to moderate active UC, and have been on stable medication for a certain period. Participants will need to provide informed consent and will be closely monitored during the trial. It’s important to note that individuals with certain conditions, like severe colitis, pregnancy, or recent use of steroids, will not be able to participate. Overall, this study is looking for ways to improve treatment options for those living with Ulcerative Colitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Informed consent
• • Established diagnosis of UC with mild to moderate active disease, 5 ≤ SCCAI ≤ 10
• • Age: 17-65 years (inclusive)
• • Extent E1-E3 by the Montreal classification
• • Active colitis in the rectum or sigmoid colon on sigmoidoscopy
• • Stable medication use of oral 5ASA for at least 8 weeks, thiopurines, vedolizumabs, Ustekinumab or tofacitinib for at least 12 weeks
• Exclusion Criteria:
• • Severe colitis (SCCAI\>10) hospitalization for acute severe colitis (ASC) in the previous 6 months
• • Use of steroids in the previous 3 months
• • Patients treated with Anti-TNF currently or in patients who had previously failed or lost response to anti TNF
• • Vegans (vegetarians may enroll)
• • Pregnancy
• • Inability use of budesonide due to severe adverse events
• • Extraintestinal manifestations such as arthritis, spondyloarthropathy or uveitis
• • Presence of baseline hypoalbuminemia
• • Fever \>38°C
• • Evidence for Clostridioides difficile infection
• • Renal failure
• • Hepatitis or PSC (Primary Sclerosing Cholangitis)
• • Active malignancy (excluding skin BCC).