Combinatietherapie van medicijnen en een dieet om remissie te bereiken bij kinderen en jongeren met milde tot matige Colitis Ulcerosa.

Recruiting

Conditions: lcerative Colitis

Registration Number: NL-OMON23813

Lead Sponsor: Amsterdam UMC, locatie AMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

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
Remission defined as PUCAI<10 at week 6

Secondary Outcome Measures

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