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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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6 June 2022 |
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Main ID: |
NCT03980405 |
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Date of registration:
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05/06/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Combination of Diet and 5ASA ( 5-aminosalicylic Acid) for Ulcerative Colitis
INDUCT |
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Scientific title:
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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 |
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Date of first enrolment:
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April 1, 2020 |
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Target sample size:
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12 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT03980405 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator).
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Phase:
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N/A
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Countries of recruitment
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Israel
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Contacts
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Name:
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Arie Levine, Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Wolfson Medical Center |
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Key inclusion & exclusion criteria
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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
Age minimum:
10 Years
Age maximum:
19 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Ulcerative Colitis
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Intervention(s)
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Dietary Supplement: Group 1- Control Diet
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Dietary Supplement: Group 2- UCD Diet
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Primary Outcome(s)
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PUCAI< 10 at week 6
[Time Frame: 6 weeks]
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Secondary Outcome(s)
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Change in UCEIS at week 12 ( optional)
[Time Frame: 12 weeks]
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Need for topical therapy by week 12
[Time Frame: 12 weeks]
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Sustained remission week 12
[Time Frame: 12 weeks]
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Tolerance to diet
[Time Frame: 12 weeks]
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A drop of PUCAI at least 10 points or remission
[Time Frame: 6 weeks]
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Mean/median change in Calprotectin at week 6
[Time Frame: 6 weeks]
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Secondary ID(s)
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0001-19-WOMC
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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