Status:
WITHDRAWN
Curcumin in Pediatric Ulcerative Colitis
Lead Sponsor:
Schneider Children's Medical Center, Israel
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
Background: Curcumin in an active phytochemical substance, used as part of the human diet, that has anti-inflammatory and anti-oxidative properties which were demonstrated in multiple experimental mod...
Detailed Description
Clinical efficacy of induction and maintenance medications in pediatric UC is limited with a cumulative long-term risk of 20%-30% for colectomy. Remission rates following induction with corticosteroid...
Eligibility Criteria
Inclusion
- Diagnosis of UC, established by the presence of accepted clinical, radiologic, endoscopic and histologic criteria.
- Age: 6 - 18 years (inclusive).
- PUCAI 10-65 at enrollment
- Negative stool culture, parasites and clostridium toxin
- Ability and acceptance to participate in the study and follow study procedures, as evidenced by a parent/legal guardian signing a written informed consent and the child providing assent.
Exclusion
- Acute severe UC (PUCAI\>65 points) requiring IV corticosteroids.
- History of two relapses or more on 5-ASA treatment.
- Pregnancy
- Sepsis or active bacterial infection
- Fever \>38.5 degrees.
- Patients whose disease is confined to the rectum (i.e. proctitis).
- Patients with crohn's colitis or with IBD type unclassified (IBD-U) according to Montreal classification.
- Rectal therapies (suppositories, foams, enemas etc) of all kind are allowed if the dose and frequency has remained stable during the previous 14 days prior to the screening visit.
- Known allergy to 5ASA, salicylates, or aminosalicylates.
- History of recurrent pancreatitis.
- Existence of current renal disease, or a screening blood urea nitrogen (BUN) or creatinine value that is \> 1.5 times the upper limit of the age appropriate normal.
- \-
Key Trial Info
Start Date :
March 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT02277223
Start Date
March 1 2020
End Date
December 31 2022
Last Update
October 1 2021
Active Locations (1)
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1
Schneider Medical Center
Petah Tikva, Israel, 4259000