Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis (NCT03980405) | Clinical Trial Compass
TerminatedNot Applicable
Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis
Stopped: It is not possible to continue the study
Israel12 participantsStarted 2020-04-01
Plain-language summary
Combination Therapy with Drug and Diet for Induction of Remission in Mild to Moderate Active Pediatric Ulcerative colitis: A Single Blinded, International Randomized Controlled Trial
Who can participate
Age range10 Years – 19 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Informed consent
✓. Established diagnosis of UC by the Paris classification and Revised Porto Criteria.
✓. Age: 10 - 19 years (inclusive)
✓. Mild to moderate active disease, 10 ≤ PUCAI ≤45
✓. Extent E2-E4 by the Paris classification
✓. Weight \>30 kg (ensures that patients who received 5ASA ≤2 grams are eligible)
✓. Stable medication (IMM/ 5ASA) use or no change in medication use for the past 6 weeks. Patients who have received topical 5ASA therapy for \<10 days and are active may be included if topical therapy is stopped at enrolment.
✓. Patients not receiving 5ASA or using 5ASA\<50mg/kg/day
Exclusion criteria
✕. Any proven current infection such as positive stool culture, parasite or C. difficile.
✕. Steroids (oral or intravenous) use in the past 3 months.
✕. Patients who continue topical 5ASA or steroids after enrolment
✕. Use of biologics in present or in past 6 months
✕. Use of antibiotics for more than one week in the past 60 days