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

May 21, 2024 updated by: Wolfson Medical Center

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel, 1834111
      • H̱olon, Israel, 58100
        • Recruiting
        • Wolfson Medical Center
        • Contact:
        • Contact:
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center
        • Contact:
  • Italy
      • Roma, Italy, 00168
        • Not yet recruiting
        • FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
        • Contact:
  • Netherlands
  • Switzerland
      • Saint Gallen, Switzerland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

17 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ulcerative colitis Exclusion Diet + Partial enteral nutrition
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.
Other: Ulcerative colitis Exclusion Diet
a limited whole food diet (UCED)
Other Names:
  • 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 Names:
  • UC nutritional formula, Nestle
Drug: Oral Budesonide
Oral Budesonide 9 mg
Active Comparator: Free diet
Participants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention
Drug: Oral Budesonide
Oral Budesonide 9 mg
Other: free diet
oral Budeosnide for 6 weeks + free diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Steroid free remission
Time Frame: week 12

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
week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: week 12
*The Simple Clinical Colitis Activity Index (SCCAI). score ranges from 0 to 19 . Clinical response defined as 3-point reduction in SCCAI or remission.
week 12
Steroids free remission
Time Frame: week 6

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
week 6
Sustained steroid free remission
Time Frame: week 24
according to SCCAI<3 at week 24 score ranges from 0 to 19. clinical remission will be defined according to SCCAI<3
week 24
Endoscopic remission
Time Frame: week 12

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.
week 12
Change in medical therapy
Time Frame: by week 12
Need for additional or change in medical therapy according to the physician decision.
by week 12
Fecal calprotectin
Time Frame: week 12
Fecal calprotectin will be analyzed locally, and will be defined as median/mean change in calprotectin from baseline.
week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wolfson Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 16, 2023

First Submitted That Met QC Criteria

March 16, 2023

First Posted (Actual)

March 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 23, 2024

Last Update Submitted That Met QC Criteria

May 21, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0073-22-WOMC

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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