MedTrace Logo

Combination of Diet and Oral Budesonide for Ulcerative Colitis

NCT05791487 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2024-05-23

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Wolfson Medical Center

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2026-03-01
Completion
2026-09-01

Countries

  • Israel
  • Italy
  • Netherlands
  • Switzerland

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05791487 on ClinicalTrials.gov