Crohn DiseaseNCT04779762
Stelara and Diet Trial for Crohn"s Disease
A study testing Crohn's disease exclusion diet (CDED) and Ustekinumab Injection [Stelara] in people with Crohn Disease, run by Wolfson Medical Center at 1 site in Israel.
Trial summary
Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Crohn's disease exclusion diet (CDED) and Ustekinumab Injection [Stelara]
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2022to Jan 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent.
- Age: 18- 65 years (inclusive).
- Established diagnosis of CD
- Starting Ustekinumab.
- Active disease defined as a CDAI >220, and have an objective measure of disease activity such as an elevated marker of inflammation (elevated CRP >5mg/L or 0.5 mg/dL or calprotectin >150 mcg/g).
- Patients must have previously received at least one dose of anti TNF at any time in the past.
- Stable medication at least 8 weeks.
- 1. Patients of any weight will be recruited and randomized to the study regardless of their BMI.
Who cannot join
- Pregnancy or lactation
- Presence of malignancy
- Use of prednisone >20 mg /day
- Ongoing use of concurrent medications with a dose change in the previous 8 weeks with the exception of steroids (Patients receiving prednisone 20 mg or less may be enrolled by must be tapered by week 6).
- Treatment with an anti TNF in the last 4 weeks.
- Patients who will take oral iron oral supplements during the trial (see comment 1 below).
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- Active infections, tuberculosis, positive stool test for Clostridium difficile toxin.
- Active perianal fistula (with discharge, or with an abscess during the past 3 months), rectovaginal fistula.
- Fever.
- Active extra intestinal disease (arthritis with joint swelling, concurrent liver disease). Patients with skin manifestations and arthralgia may be included.
- Smokers who smoke >5 more cigarettes a day (see comment 2 below).
- Renal failure.
- Uncontrolled diabetes that precludes the diet.
- Patients with isolated colonic disease distal to the transverse colon (see comment 3 below).
- Patients taking oral iron supplements may be enrolled if they discontinue the supplements prior to receiving UST, and are NOT ALLOWED to take oral iron supplements during the first 12 weeks of the trial as the diet reduces oral iron exposure to decrease siderophoric pathobionts (patients are allowed to receive intravenous iron or other oral vitamins during the trial).
- Patients who smoke >5 cigarettes per day may be enrolled if they stop smoking from the start of the trial (smoking negates the effect of the diet).
- Patients with isolated colonic disease distal to the transverse colon and no history of ileal disease will be excluded to make sure that IBDU is not recruited.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stelara and CDED Diet Trial for Crohn"s Disease
Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing.
The goal of the current pilot study is to evaluate the added benefit of treatment with Ustekinumab combined with CDED in anti TNF exposed patients compared to treatment with Ustekinumab alone in term of achieving remission.
Read the detailed description
The induction period is crucial for a patient's response to biologic therapy but also for maintenance of remission, as simple as it sounds, maintenance of remission requires remission. Biological medications using a single monoclonal antibody directed target, seem to be effective only for a segment of the population with Crohn's disease Dietary therapy is highly effective in children and induces remission in approximately 60% of young adults with uncomplicated luminal disease. It was shown to shift the microbiome away from Proteobacteria towards Firmicutes, and to decrease intestinal permeability (i.e improvement in leaky gut).
Dietary therapy is widely used in children and both exclusive enteral nutrition (EEN) and the Crohn's disease exclusion diet were highly effective for induction of remission and reduction in inflammation in children in a multinational randomized controlled trial (Levine A, Gastroenterology 2019). Recently a prospective randomized controlled trial in biologic naïve adults demonstrated clinical remission in 62% of adults by 6 weeks (Yanai H, UEG Week 2020). A two week course of EEN in adults was effective for improvement of symptoms and reduction in inflammation (Wall CL Inflamm Intest Dis 2018). Xu et al demonstrated clinical remission in 52 and 47% of two adult cohorts (n=104) using EEN for induction of remission (Xu Y, Therap Adv Gastroenterol 2019). Taken together, these studies suggest that dietary therapy could act as a bridge to biologic effect and have a synergistic effect on the disease.
- Conditions
- Crohn Disease
- Being tested
- Crohn's disease exclusion diet (CDED), Ustekinumab Injection [Stelara]
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crohn's disease exclusion diet (CDED)Other
Dietary therapy for Crohn's disease
Ustekinumab Injection [Stelara]Drug
Drug for Crohn's disease
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Experimental | Standard induction regimen of Ustekinumab with the Crohn's disease exclusion diet (CDED) Receives: Other: Crohn's disease exclusion diet (CDED); Drug: Ustekinumab Injection [Stelara] |
| Group 2 | Active comparator | Standard induction regimen of Ustekinumab as above without diet Receives: Drug: Ustekinumab Injection [Stelara] |
What is being measured
The primary outcome is the main question the study is designed to answer.
ITT, steroid free remission
Defined as an improvement in one inflammatory marker (CRP or calprotectin)
Measured: week 12
Secondary outcomes (4)
Median calprotectin
Reduction in median calprotectin compared to baseline between groups
Measured: week 12
Intestinal bowel wall thickness
Reduction in intestinal bowel wall thickness compared to baseline between groups for patients with increased bowel wall thickness measured on baseline US.
Measured: week 16
UST trough level
mean UST trough level between groups.
Measured: week 16
CDAI between groups
Median decline in CDAI between groups. Crohn's Disease Activity Index (CDAI) range between 0-800
Measured: week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2021
- Study startJan 2022 (estimated)
- Primary completionJan 2025 (estimated)
- Study completionJan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies 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
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wolfson Medical Center
- Sponsor type
- Other government
- Collaborators
- Sheba Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04779762
- Sponsor's protocol ID
- STEDI
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2021
- Last updated
- 3 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stelara and CDED Diet Trial for Crohn"s Disease
- ClinicalTrials.gov ID
- NCT04779762
- Acronym / sponsor ID
- STEDI
- Conditions
- Crohn Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wolfson Medical CenterOther government
- Collaborators
- Sheba Medical Center
- Study start
- Jan 2022 (estimated)
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2026 (estimated)
- First posted
- 3 Mar 2021 (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.
Dietary therapy involving the Crohn's disease exclusion diet (CDED) is an evolving strategy to target the microbiome and innate immunity in order to reduce inflammation and promote healing.
The goal of the current pilot study is to evaluate the added benefit of treatment with Ustekinumab combined with CDED in anti TNF exposed patients compared to treatment with Ustekinumab alone in term of achieving remission.
Detailed description
The induction period is crucial for a patient's response to biologic therapy but also for maintenance of remission, as simple as it sounds, maintenance of remission requires remission. Biological medications using a single monoclonal antibody directed target, seem to be effective only for a segment of the population with Crohn's disease Dietary therapy is highly effective in children and induces remission in approximately 60% of young adults with uncomplicated luminal disease. It was shown to shift the microbiome away from Proteobacteria towards Firmicutes, and to decrease intestinal permeability (i.e improvement in leaky gut).
Dietary therapy is widely used in children and both exclusive enteral nutrition (EEN) and the Crohn's disease exclusion diet were highly effective for induction of remission and reduction in inflammation in children in a multinational randomized controlled trial (Levine A, Gastroenterology 2019). Recently a prospective randomized controlled trial in biologic naïve adults demonstrated clinical remission in 62% of adults by 6 weeks (Yanai H, UEG Week 2020). A two week course of EEN in adults was effective for improvement of symptoms and reduction in inflammation (Wall CL Inflamm Intest Dis 2018). Xu et al demonstrated clinical remission in 52 and 47% of two adult cohorts (n=104) using EEN for induction of remission (Xu Y, Therap Adv Gastroenterol 2019). Taken together, these studies suggest that dietary therapy could act as a bridge to biologic effect and have a synergistic effect on the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Experimental | Other: Crohn's disease exclusion diet (CDED), Drug: Ustekinumab Injection [Stelara]Standard induction regimen of Ustekinumab with the Crohn's disease exclusion diet (CDED) |
| Group 2 | Active comparator | Drug: Ustekinumab Injection [Stelara]Standard induction regimen of Ustekinumab as above without diet |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Informed consent.
- Age: 18- 65 years (inclusive).
- Established diagnosis of CD
- Starting Ustekinumab.
- Active disease defined as a CDAI >220, and have an objective measure of disease activity such as an elevated marker of inflammation (elevated CRP >5mg/L or 0.5 mg/dL or calprotectin >150 mcg/g).
Key exclusion criteria (17 listed)
- Pregnancy or lactation
- Presence of malignancy
- Use of prednisone >20 mg /day
- Ongoing use of concurrent medications with a dose change in the previous 8 weeks with the exception of steroids (Patients receiving prednisone 20 mg or less may be enrolled by must be tapered by week 6).
- Treatment with an anti TNF in the last 4 weeks.
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 |
|---|---|---|
| Crohn's disease exclusion diet (CDED)Dietary therapy for Crohn's disease | Other | Group 1 |
| Ustekinumab Injection [Stelara]Drug for Crohn's disease | Drug | Group 1, Group 2 |
Primary outcome
ITT, steroid free remission
Time frame: week 12
Defined as an improvement in one inflammatory marker (CRP or calprotectin)
4 secondary outcomes
Median calprotectin
Time frame: week 12
Intestinal bowel wall thickness
Time frame: week 16
UST trough level
Time frame: week 16
CDAI between groups
Time frame: week 16
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Crohn's disease exclusion diet (CDED) and Ustekinumab Injection [Stelara] in people with Crohn Disease, run by Wolfson Medical Center at 1 site in Israel.
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 8 inclusion and 17 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 3 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. 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?
Contact Michal Yaakov, Ph.D (972-35028878, michal.yaakov@walla.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ITT, 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?
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 3 Mar 2021.