NL-OMON23813RecruitingNot Applicable
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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Amsterdam UMC, locatie AMC
- Enrollment
- 10
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
Inclusion Criteria
- •1. Informed consent
- •2. Established diagnosis of UC by the Paris classification and Revised Porto Criteria.
- •3. Age: 10 – 19 years (inclusive)
- •4. Mild to moderate active disease, 10 = PUCAI =45
- •5. Extent E2-E4 by the Paris classification
- •6. Weight >30 kg (ensures that patients who received 5ASA =2 grams are eligible)
- •7. 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
- •8. Patients not receiving 5ASA or using 5ASA<50mg/kg/day
Exclusion Criteria
- •1. Any proven current infection such as positive stool culture, parasite or C. difficile.
- •2. Steroids (oral or intravenous) use in the past 3 months.
- •3. Patients who continue topical 5ASA or steroids after enrolment
- •4. Use of biologics in present or in past 6 months
- •5. Use of antibiotics for more than one week in the past 60 days
- •6. PUCAI >45
- •7. Acute severe UC in the previous 12 months.
- •8. Current extra intestinal manifestation of UC.
- •9. PSC or Liver disease
- •10. Pregnancy.
- •11. Vegans or patients unwilling or unable to consume eggs
- •12. IBD unclassified
- •Exclusion criteria Comments:
- •1. Stool culture, parasite or C. difficile will only be measured if the patient has diarrhea.
- •2. Patients who have received treatment enemas for 3 weeks or less then 3 days and are active, can be included
- •but must stop the enemas on the day of enrolment
Investigators
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