Overview

Use of a Novel Diet (UC DIET) for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis

Status:
Recruiting

Trial end date:
2021-12-01

Target enrollment:
0

Participant gender:
All

Summary

The goal of the study is to evaluate strategies that target the microbiota for the treatment of Ulcerative Colitis , This study will involve a novel diet that the investigators developed , based on the hypothesis that UC involves dysbiosis , underutilzation of certain metabolic pathways and use of pathways that increase risk of inflammation . The investigators have postulated that manipulation of colonic bacterial metabolism with this diet will induce remission in UC without involving additional immune suppression.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Prof. Arie Levine

Treatments:

Amoxicillin
Anti-Bacterial Agents
Antibiotics, Antitubercular
Doxycycline
Metronidazole

Criteria

Inclusion Criteria:

1. Informed consent

2. Established diagnosis of UC.

3. Age: 8 - 19 years ( inclusive)

4. Mild to moderate active disease, 10 ≤ PUCAI ≤45.

5. Stable medication (IMM/ 5ASA) use for the past 6 weeks. Patients who have received
topical 5ASA therapy for <7 days and are active may be included if topical therapy is
stopped at enrolment

Exclusion Criteria:

Exclusion criteria:

1. Any proven current infection such as positive stool culture, parasite or C. difficile.

2. Antibiotic or Steroids use in the past 2 weeks.

3. PUCAI >45

4. Acute severe UC in the previous 12 months.

5. Current Extra intestinal manifestation of UC.

6. PSC or Liver disease

7. Pregnancy.

8. Allergy to one of the antibiotics or age <11 will exclude patients from entering the
antibiotic arm