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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 10 Years - 19 Years
Gender All
More Inclusion & Exclusion 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 enrolment. 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. Primary Sclerosing Cholangitis (PSC) or Liver disease. 10. Pregnancy. 11. Vegans or patients unwilling or unable to consume eggs. 12. Inflammatory Bowel Disease (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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03980405
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Prof. Arie Levine
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Arie Levine, Prof
Principal Investigator Affiliation Wolfson Medical Center
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Israel
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Ulcerative Colitis
Additional Details

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.

Arms & Interventions

Arms

Experimental: Group 1

Control Diet 6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ Low residue diet and 6 more weeks of Oral 5ASA+ Free diet

Experimental: Group 2

6 weeks of Oral 5ASA (standard recommended dosing 60-75 mg/kg/day; minimum 2.5, maximum 4 grams/day)+ UC diet and 6 more weeks of Oral 5ASA+ UC diet stage 2

Interventions

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

Contact a Trial Team

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International Sites

Wolfson MC, Holon, Israel

Status

Recruiting

Address

Wolfson MC

Holon, , 5822012

Site Contact

Michal Yaakov, Phd

michaly@wmc.gov.il

972-3-5028878

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