Combination of Diet and Oral Budesonide for Ulcerative Colitis

ConditionsUlcerative Colitis Ulcerative Colitis Chronic Mild Ulcerative Colitis Chronic Moderate

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age17-65

SponsorWolfson Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

90 Participants

are divided into 2 treatment groups

Group A: Ulcerative colitis Exclusion Diet + Partial enteral nutritionExperimental treatment 3 interventions

Group B: Free dietActive comparator 2 interventions

Trial outcomes

Primary outcomes

Steroid free remission

Steroid free intention-to-treat (ITT) remission according to SCCAI\<3 at week 12 \*The Simple Clinical Colitis Activity Index (SCCAI). score ranges from 0 to 19. clinical remission will be defined according to SCCAI\<3

Time frame

week 12

Secondary outcomes

Clinical response

\*The Simple Clinical Colitis Activity Index (SCCAI). score ranges from 0 to 19 . Clinical response defined as 3-point reduction in SCCAI or remission.

Time frame

week 12

Steroids free remission

Steroid free intention-to-treat (ITT) remission according to SCCAI\<3 at week 6 \*The Simple Clinical Colitis Activity Index (SCCAI). score ranges from 0 to 19. clinical remission will be defined according to SCCAI\<3

Time frame

week 6

Sustained steroid free remission

according to SCCAI\<3 at week 24 score ranges from 0 to 19. clinical remission will be defined according to SCCAI\<3

Time frame

week 24

Endoscopic remission

Defined as Mayo score 0 or 1. Mayo score 0 or 1 means endoscopic remission. \*The Mayo Score for ulcerative colitis disease activity provides an assessement of disease severity and can be used to monitor patients during therapy.

Time frame

week 12