NCT03980405

Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Prof. Arie Levine · Other Government
• Sex: All
• Age: 10 Years – 19 Years
• Healthy volunteers: Not accepted

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

Detailed description

This will be a 12 week, single blinded Randomized controlled trial (RCT) in children and adolescents with mild to moderate Ulcerative Collitis (UC) comparing 5ASA (recommended dosing 60-75 mg/kg/day; minimum 2.5 maximum 4 grams/day) with fiber restriction for 6 weeks followed by free diet (Group 1) to 5ASA with Ulcerative Collitis Diet (UCD) for 6 weeks, followed by the step down UCD for the next 6 weeks. Inclusion criteria will include children weighing \>30kg, Pediatric Ulcerative Collitis Activity index (PUCAI) 10-45, no treatment with 5ASA (treatment naïve or treated with thiopurines for example) or currently treatment with 5ASA but \<2 grams/day, ages 10-19 years, with disease extent E2-E4 by the Paris Classification. Patients on thiopurines may continue existing dose if dose is stable for at least 8 weeks. Exclusion criteria are Patients with acute severe colitis (ASC) in the previous year, requiring oral or intravenous steroids in the previous 3 months, or patients treated with Anti- Tumor necrosis factor alfa (TNFa) regimens. Importantly, there is no placebo arm and both groups will be treated with the same currently recommended drug at currently recommended doses; the only difference between groups being their diets. The primary endpoint will be remission defined as PUCAI\<10 at week 6; Secondary endpoints will be response defined as a drop in PUCAI of 10 or remission at week 6, sustained steroid free remission week 12 and improvement in mucosal healing by Ulcerative Colitis Endoscopic Index of Severity (UCEIS) at week 12 as well as safety and tolerance. Intolerance will be defined as patients stopping the diet because of refusal to continue diet. Patients will be seen at weeks 0, 3, 6, and 12. PUCAI will be assessed at every visit; fecal calprotectin will be assessed at baseline, week 6 and 12. Sigmoidoscopy to assess mucosal healing will be performed at week 12 in patients who had a baseline colonoscopy or sigmoidoscopy. Sigmoidoscopies to evaluate healing will be voluntary and patients will not be excluded if they do not consent to have a follow up sigmoidoscopy.

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Group 1- Control Diet	Oral 5ASA+ Low Residue Diet for 6 weeks and Oral 5ASA+ Free Diet for 6 more weeks
DIETARY_SUPPLEMENT	Group 2- UCD Diet	Oral 5ASA+ UC Diet for 6 weeks and Oral 5ASA+ UC Diet Stage 2 for 6 more weeks

Timeline

• Start date: 2020-04-01
• Primary completion: 2022-05-30
• Completion: 2022-05-30
• First posted: 2019-06-10
• Last updated: 2022-06-01

Locations

1 site across 1 country: Israel