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

Completed

Conditions: chronic bowel inflammation
Inflammatory bowel disease
10017969

Registration Number: NL-OMON54904

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

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. 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Remission defined as PUCAI<10 at week 6</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinical Secondary End Points:<br /><br>- Response defined as a drop of PUCAI at least 10 points or remission<br /><br>(intention to treat) week 6 .<br /><br>- Mean/median change in Calprotectin at week 6<br /><br>- Sustained steroid & biologic free remission week 12<br /><br>- Need for topical therapy by week 12<br /><br>- Change in UCDEIS at week 12 ( optional)<br /><br>- Tolerance to diet defined by withdrawal from the study because of<br /><br>difficulties with the diet.<br /><br><br /><br>Translational Secondary End Points:<br /><br>- Changes to the microbiome: diet vs. no diet<br /><br>- Change in microbiome: remission vs. failures<br /><br>- Short chain fatty acids in stool by group week 6</p><br>