NCT05791487

Combination of Diet and Oral Budesonide for Ulcerative Colitis

Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Wolfson Medical Center · Other Government
• Sex: All
• Age: 17 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Ulcerative Colitis
• Ulcerative Colitis Chronic Mild
• Ulcerative Colitis Chronic Moderate

Interventions

Type	Name	Description
OTHER	Ulcerative colitis Exclusion Diet	a limited whole food diet (UCED)
OTHER	Partial enteral nutrition (PEN)	The diet will be supplemented by 3 glasses a day (750 m"l) of the formula developed for UC using the UCED principles.
OTHER	free diet	oral Budeosnide for 6 weeks + free diet
DRUG	Oral Budesonide	Oral Budesonide 9 mg

Timeline

• Start date: 2023-12-01
• Primary completion: 2026-03-01
• Completion: 2026-09-01
• First posted: 2023-03-30
• Last updated: 2024-05-23

Locations

6 sites across 4 countries: Israel, Italy, Netherlands, Switzerland