Status:
TERMINATED
Use of the Ulcerative Colitis Diet for Induction of Remission
Lead Sponsor:
Prof. Arie Levine
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
5-18 years
Phase:
NA
Brief Summary
The goal of the study is to evaluate the use of Ulcerative Colitis Diet for Induction of Remission. The investigators have postulated that we developed could be beneficial for patients with Ulcerative...
Detailed Description
Background: Recent research has shown that dietary components may lead to impaired intestinal innate immunity due to alterations in the microbiome, mucous layer, intestinal permeability or change in ...
Eligibility Criteria
Inclusion
- Informed consent
- Established diagnosis of UC disease.
- Age: 5 - 18 years ( inclusive)
- Mild to moderate active disease, 10 ≤ PUCAI ≤45.
- Stable medication (IMM/ 5ASA) use for the past 6 weeks.
- For patients who received antibiotic treatment: age 10-18 (inclusive).
Exclusion
- Any proven infection such as positive stool culture, parasite or C.difficile.
- Use of Antibiotics
- Use of steroids in the previous two weeks only
- Patients that are refractory to full dose steroids ( 1 mg/kg/day)
- Past acute severe UC.
- Current Extra intestinal manifestation of UC.
- Pregnancy.
- A subset of patients who are on steroids and relapse during steroids treatment ≤0.5 mg/kg with mild to moderate disease activity will act as a second subset for this exploratory study.
- \-
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT02217722
Start Date
October 1 2014
End Date
February 1 2016
Last Update
August 11 2016
Active Locations (1)
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1
The E.Wolfson Medical Center
Holon, Israel, 58100