Ulcerative ColitisReDUCENCT05791487
Combination of Diet and Oral Budesonide for Ulcerative Colitis
A study testing Ulcerative colitis Exclusion Diet, Partial enteral nutrition (PEN) and free diet in people with Ulcerative Colitis and Ulcerative Colitis Chronic Mild, run by Wolfson Medical Center at 6 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 17 to 65 years
- Conditions the study is for
- Ulcerative Colitis, Ulcerative Colitis Chronic Mild, Ulcerative Colitis Chronic Moderate
- What is being tested?
- Ulcerative colitis Exclusion Diet, Partial enteral nutrition (PEN) and free diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 6 sitesin 4 countries
- Study dates
- 1 Dec 2023to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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 locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
Israel3 sites, 3 recruiting
- Not yet recruiting
Emek Medical Center
Afula, 1834111
Eran Zittan, MD, eranzittan@clalit.org.il
- Recruiting
Wolfson Medical Center
Holon, 58100
Eran Israeli, Professor, 972-52-5912199, erani@wmc.gov.il
Chen Sarbagili, RD, 972-52-5912199, ibd.chen@gmail.com
- Recruiting
Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906
Nitsan Maharshak, Professor, 972-52-7360384, nitsanm@tlvmc.gov.il
Italy1 site, 1 recruiting
- Not yet recruiting
FONDAZIONE GEMELLI HOSPITAL Catholic University of the Sacred Hearth
Roma, 00168
Franco Scaldaferri, MD, PhD, +390630155923, francoscaldaferri@gmail.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Radboud University Medical Center (Radboudumc)
Nijmegen
Marjolijn Duijvestein, MD, PhD, marjolijn.Duijvestein@radboudumc.nl
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital St. Gallen
Sankt Gallen
Claudia Krieger-Grübel, MD, +417977390545, Claudia.Krieger-Gruebel@kssg.ch
About this study
Official title: 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.
Read the 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.
- Being tested
- Ulcerative colitis Exclusion Diet, Partial enteral nutrition (PEN), free diet, Oral Budesonide
- Keywords
- Ulcerative colitis, Diet, Partial enteral nutrition, Microbiome
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ulcerative colitis Exclusion DietOther
Also called UCED
a limited whole food diet (UCED)
Partial enteral nutrition (PEN)Other
Also called UC nutritional formula, Nestle
The diet will be supplemented by 3 glasses a day (750 m"l) of the formula developed for UC using the UCED principles.
free dietOther
oral Budeosnide for 6 weeks + free diet
Oral BudesonideDrug
Oral Budesonide 9 mg
| Study group | Role | What they receive |
|---|---|---|
| Ulcerative colitis Exclusion Diet + Partial enteral nutrition | Experimental | 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. Receives: Other: Ulcerative colitis Exclusion Diet; Other: Partial enteral nutrition (PEN); Drug: Oral Budesonide |
| Free diet | Active comparator | Participants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention Receives: Other: free diet; Drug: Oral Budesonide |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: week 12
Secondary outcomes (6)
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.
Measured: 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
Measured: 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
Measured: 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.
Measured: week 12
Change in medical therapy
Need for additional or change in medical therapy according to the physician decision.
Measured: by week 12
Fecal calprotectin
Fecal calprotectin will be analyzed locally, and will be defined as median/mean change in calprotectin from baseline.
Measured: week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05791487
- Sponsor's protocol ID
- 0073-22-WOMC
- Acronym
- ReDUCE
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 23 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.
PubMed 34514495Sarbagili-Shabat C, Albenberg L, Van Limbergen J, Pressman N, Otley A, Yaakov M, Wine E, Weiner D, Levine A. A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study. Nutrients. 2021 Oct 23;13(11):3736. doi: 10.3390/nu13113736.
PubMed 34835992
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remission With Diet for Ulcerative Colitis Exacerbations: A Single Blinded, International Randomized Controlled Clinical and Translational Trial
- ClinicalTrials.gov ID
- NCT05791487
- Acronym / sponsor ID
- ReDUCE / 0073-22-WOMC
- Keywords
- Ulcerative colitis, Diet, Partial enteral nutrition, Microbiome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 30 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ulcerative colitis Exclusion Diet + Partial enteral nutrition | Experimental | Other: Ulcerative colitis Exclusion Diet, Other: Partial enteral nutrition (PEN), Drug: Oral BudesonideParticipants 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. |
| Free diet | Active comparator | Other: free diet, Drug: Oral BudesonideParticipants in Group 2 will receive oral budesonide 9 mg topical therapy alone for 6 weeks with no dietary intervention |
Who may qualify
- Ages
- 17 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ulcerative colitis Exclusion DietAlso: UCEDa limited whole food diet (UCED) | Other | Ulcerative colitis Exclusion Diet + Partial enteral nutrition |
| Partial enteral nutrition (PEN)Also: UC nutritional formula, NestleThe diet will be supplemented by 3 glasses a day (750 m"l) of the formula developed for UC using the UCED principles. | Other | Ulcerative colitis Exclusion Diet + Partial enteral nutrition |
| free dietoral Budeosnide for 6 weeks + free diet | Other | Free diet |
| Oral BudesonideOral Budesonide 9 mg | Drug | Free diet, Ulcerative colitis Exclusion Diet + Partial enteral nutrition |
Primary outcome
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
6 secondary outcomes
Clinical response
Time frame: week 12
Steroids free remission
Time frame: week 6
Sustained steroid free remission
Time frame: week 24
Endoscopic remission
Time frame: week 12
Change in medical therapy
Time frame: by week 12
Fecal calprotectin
Time frame: week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2024.
- Background: PubMed 34514495Sarbagili Shabat C, Scaldaferri F, Zittan E, Hirsch A, Mentella MC, Musca T, Cohen NA, Ron Y, Fliss Isakov N, Pfeffer J, Yaakov M, Fanali C, Turchini L, Masucci L, Quaranta G, Kolonimos N, Godneva A, Weinberger A, Kopylov U, Levine A, Maharshak N. Use of Faecal Transplantation with a Novel Diet for Mild to Moderate Active Ulcerative Colitis: The CRAFT UC Randomised Controlled Trial. J Crohns Colitis. 2022 Mar 14;16(3):369-378. doi: 10.1093/ecco-jcc/jjab165.
- Background: PubMed 34835992Sarbagili-Shabat C, Albenberg L, Van Limbergen J, Pressman N, Otley A, Yaakov M, Wine E, Weiner D, Levine A. A Novel UC Exclusion Diet and Antibiotics for Treatment of Mild to Moderate Pediatric Ulcerative Colitis: A Prospective Open-Label Pilot Study. Nutrients. 2021 Oct 23;13(11):3736. doi: 10.3390/nu13113736.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ulcerative colitis Exclusion Diet, Partial enteral nutrition (PEN) and free diet in people with Ulcerative Colitis and Ulcerative Colitis Chronic Mild, run by Wolfson Medical Center at 6 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Israel, Italy, Netherlands, Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Steroid free remission (time frame: week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05791487, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2024.