Stelara and Diet Trial for Crohn"s Disease

NCT04779762 | Unknown

• 1 other identifier: STEDI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Crohn Disease

Outcome Measures

Primary Outcomes (1)

• ITT, steroid free remission

  Defined as an improvement in one inflammatory marker (CRP or calprotectin)

  week 12

Secondary Outcomes (4)

• Median calprotectin

  week 12

• Intestinal bowel wall thickness

  week 16

• UST trough level

  week 16

• CDAI between groups

  week 16

Study Arms (2)

Group 1

EXPERIMENTAL

Standard induction regimen of Ustekinumab with the Crohn's disease exclusion diet (CDED)

Other: Crohn's disease exclusion diet (CDED); Drug: Ustekinumab Injection [Stelara]

Group 2

ACTIVE COMPARATOR

Standard induction regimen of Ustekinumab as above without diet

Drug: Ustekinumab Injection [Stelara]

Interventions

Crohn's disease exclusion diet (CDED) OTHER

Dietary therapy for Crohn's disease

Group 1

Ustekinumab Injection [Stelara] DRUG

Drug for Crohn's disease

Group 1; Group 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Patients of any weight will be recruited and randomized to the study regardless of their BMI.

You may not qualify if:

• 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).
• 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).

Sponsors & Collaborators

• Wolfson Medical Center: lead
• Sheba Medical Center: collaborator

Study Sites (1)

Sheba Medical Center

Ramat Gan, 5262000, Israel

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Ustekinumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Michal Yaakov, Ph.D

CONTACT

972-35028878; michal.yaakov@walla.co.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2021
• First Posted: March 3, 2021
• Study Start: January 1, 2022
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2026
• Last Updated: March 3, 2021

Record last verified: 2021-02

Locations

IL (1)