Combination of Diet and Oral Budesonide for Ulcerative Colitis (ReDUCE)

Wolfson Medical Center (WMC)

Status: Enrolling

Conditions: Ulcerative Colitis Chronic Mild; Ulcerative Colitis; Ulcerative Colitis Chronic Moderate

Treatments: Other: Partial enteral nutrition (PEN); Other: Ulcerative colitis Exclusion Diet; Other: free diet; Drug: Oral Budesonide

Study type: Interventional

Funder types: Other

Identifiers

NCT05791487

0073-22-WOMC

Details and patient eligibility

About

The ReDUCE Trial is a multinational single-blinded randomized controlled trial in mild to moderate flare of Ulcerative colitis (UC) disease patients. The purpose of the study is to validate the clinical efficacy of the UCED (Ulcerative colitis Exclusion Diet) with partial enteral nutrition (PEN) using a novel formula.

The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.

Full description

Rational: Ulcerative colitis is currently treated only by medical therapies or surgery and there is no other option to avoid immune suppression.

Thus, developing a dietary therapy that would treat the cause of the disease, while having no side effects, would likely lead to immediate implementation and be sought out by patients hesitant to be on lifelong medications or immune suppression.

Objectives: To evaluate if the UC Exclusion Diet (UCED), can improve outcomes when administered with an oral budesonide regimen to adult patients with mild to moderate UC.

Methods: This will be a 24-week multinational single-blinded randomized controlled trial.

After a baseline flexible sigmoidoscopy, Group 1 will receive oral budesonide 9 mg topical therapy + the UCED+PEN phase 1 diet for 6 weeks, while Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention.

Both groups will continue the previous maintenance therapy through week 12 and both groups will stop budesonide at week 6.

Group 1 will continue with the phase 2 diet/PEN from week 7-12 while group 2 will stay on habitual diet. A flexible sigmoidoscopy will be repeated at week 12.

Population: adults and adolescents between the ages of 17-65 with a mild to moderate active disease (Simple Clinical Colitis Activity Index (SCCAI) 5-10 with an endoscopic Mayo score 1-3), on an existing maintenance therapy comparing two arms.

Time frame: The induction of remission phase will last 8 weeks followed by maintenance phase for a period of 24 weeks

Expected outcomes and significance: The investigators anticipate that adding a novel specifically designed dietary intervention in addition to drug will lead to superior remission and mucosal healing via changes in the microbiome.

Enrollment: 90 estimated patients

Sex: All

Ages: 17 to 65 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Ulcerative colitis Exclusion Diet + Partial enteral nutrition

Experimental group

Description:

Participants in Group 1 will receive the UCED combined with partial enteral nutrition (PEN) using a novel nutritional formula for 6 weeks (diet phase 1) that will add to oral budesonide 9 mg topical therapy for 6 weeks and will follow diet + PEN (phase 2: wk6-wk12) and diet phase 3 for 24 weeks.

Treatment:

Drug: Oral Budesonide

Other: Ulcerative colitis Exclusion Diet

Other: Partial enteral nutrition (PEN)

Free diet

Active Comparator group

Description:

Participants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention

Treatment:

Drug: Oral Budesonide

Other: free diet