Status:
NOT_YET_RECRUITING
Stelara and Diet Trial for Crohn"s Disease
Lead Sponsor:
Wolfson Medical Center
Collaborating Sponsors:
Sheba Medical Center
Conditions:
Crohn Disease
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief 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. The goal ...
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 medi...
Eligibility Criteria
Inclusion
- 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.
- Inclusion criteria comments
- 1\. Patients of any weight will be recruited and randomized to the study regardless of their BMI.
Exclusion
- 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).
- 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).
- Exclusion criteria comments
- 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.
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04779762
Start Date
January 1 2022
End Date
January 1 2026
Last Update
March 3 2021
Active Locations (1)
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1
Sheba Medical Center
Ramat Gan, Israel, 5262000