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

NCT03980405 | Terminated

• 1 other identifier: 0001-19-WOMC
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Ulcerative Colitis

Outcome Measures

Primary Outcomes (1)

• PUCAI< 10 at week 6

  Remission defined as PUCAI\<10 at week 6

  6 weeks

Secondary Outcomes (6)

• A drop of PUCAI at least 10 points or remission

  6 weeks

• Mean/median change in Calprotectin at week 6

  6 weeks

• Sustained remission week 12

  12 weeks

• Need for topical therapy by week 12

  12 weeks

• Change in UCEIS at week 12 ( optional)

  12 weeks

Study Arms (2)

Group 1

EXPERIMENTAL

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

Dietary Supplement: Group 1- Control Diet

Group 2

EXPERIMENTAL

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

Dietary Supplement: Group 2- UCD Diet

Interventions

Group 1- Control Diet DIETARY_SUPPLEMENT

Oral 5ASA+ Low Residue Diet for 6 weeks and Oral 5ASA+ Free Diet for 6 more weeks

Group 1

Group 2- UCD Diet DIETARY_SUPPLEMENT

Oral 5ASA+ UC Diet for 6 weeks and Oral 5ASA+ UC Diet Stage 2 for 6 more weeks

Group 2

Eligibility Criteria

• Age: 10 Years - 19 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• PUCAI \>45
• Acute severe UC in the previous 12 months.
• Current extra intestinal manifestation of UC.
• Primary Sclerosing Cholangitis (PSC) or Liver disease
• Pregnancy.
• Vegans or patients unwilling or unable to consume eggs
• Inflammatory Bowel Disease (IBD) unclassified
• Stool culture, parasite or C. difficile will only be measured if the patient has diarrhea.
• 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

Sponsors & Collaborators

• Prof. Arie Levine: lead

Study Sites (1)

Wolfson MC

Holon, 5822012, Israel

Location

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Arie Levine, Prof

  Wolfson Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Physicians will be blinded to the randomization and dietary advice received
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Pediatric Gastroenterology and nutrition unit

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 10, 2019
• Study Start: April 1, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)