Stelara and Diet Trial for Crohn"s Disease

• Status: Not yet recruiting
• Trial end date: 2026-01-01
• Target enrollment: 0
• Participant gender: All

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 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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wolfson Medical Center
• Collaborator: Sheba Medical Center, Israel
• Treatments: Ustekinumab

Criteria

Inclusion Criteria:

1. Informed consent.

2. Age: 18- 65 years (inclusive).

3. Established diagnosis of CD

4. Starting Ustekinumab.

5. 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).

6. Patients must have previously received at least one dose of anti TNF at any time in the past.

7. 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 Criteria:

1. Pregnancy or lactation

2. Presence of malignancy

3. Use of prednisone >20 mg /day

4. 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).

5. Treatment with an anti TNF in the last 4 weeks.

6. Patients who will take oral iron oral supplements during the trial (see comment 1 below).

7. Active infections, tuberculosis, positive stool test for Clostridium difficile toxin.

8. Active perianal fistula (with discharge, or with an abscess during the past 3 months), rectovaginal fistula.

9. Fever.

10. Active extra intestinal disease (arthritis with joint swelling, concurrent liver disease). Patients with skin manifestations and arthralgia may be included.

11. Smokers who smoke >5 more cigarettes a day (see comment 2 below).

12. Renal failure.

13. Uncontrolled diabetes that precludes the diet.

14. Patients with isolated colonic disease distal to the transverse colon (see comment 3 below).

Exclusion criteria comments

1. 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).

2. 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).

3. 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.