Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patien… (NCT06777706) | Clinical Trial Compass
CompletedNot Applicable
Open Label Study to Assess Safety & Efficacy of QD for Induction of Remission in Pediatric Patients with UC
Israel20 participantsStarted 2023-01-01
Plain-language summary
To date, there are no reports on the use of QD in pediatric patients with UC. There is a great need to increase the repertoire of anti-inflammatory interventions for remission induction, especially in children given the notorious side effects of steroids on growth. Importantly, no prescription is needed to acquire QD, as this is a food supplement that can be purchased over the counter. We wish to assess the efficacy and safety of QD as induction therapy in pediatric patients with mild-moderate active UC.
Who can participate
Age range4 Years – 17 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
✓. Established diagnosis of UC for at least one month based on accepted criteria15.
✓. Age 4-17.9 years old (inclusive).
✓. Weight ≥ 15kg
✓. PUCAI 10-60 at enrollment (reflecting mild-moderate UC).
✓. If a patient is receiving oral 5-ASA, the dose must be stable for at least 4 weeks prior to inclusion.
✓. If patient is receiving immunomodulator medication (azathioprine or 6- mercaptopurine), dose must be stable for at least 3 months prior to inclusion.
✓. If a patient is on topical 5-ASA (suppositories or enema) the dose must be stable for at least 2 weeks prior to inclusion and will not be altered throughout the 6-week study period.
✓. Negative stool culture, parasites and clostridium difficile testing.
Exclusion criteria
✕. Acute severe colitis (PUCAI\>65).
✕. Patient with chronic renal or liver disease, hypertension, cardiovascular disease, cerebrovascular disease, chronic pancreatitis, diabetes mellitus, gallstone disease, previous malignancy, uncontrolled migraines or neurological disorders.
✕. Abnormal liver enzymes (ALT, AST, GGT) X2 times upper normal limit.
✕. Patients whose disease is confined to the rectum (i.e. proctitis).