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

Ulcerative colitis is a chronic inflammatory disease primarily involving the colon. It has
long been considered to be due to a dysregulated immune response targeting the colon, and
involves unknown environmental factors . Recent studies have highlighted several
characteristics which may suggest that UC is associated with alterations of the microbiota,
defective production of short chain fatty acids and an impaired mucous layer. However at
present, no effective therapy targets the microbiota or its interaction with the colonic
epithelium. UC in humans is characterized by increased mucosal sulfides and increased sulfate
and sulfide reducing bacteria and activation of amino acid metabolism pathways which impair
butyrate production, whereas certain dietary patterns in humans and rodent models may induce
dysbiosis and favor sulphide reducing bacteria. Further support for targeting the microbiota
includes several studies demonstrating that antibiotics might be helpful for severe
refractory colitis. Development of treatment strategies that target the microbiota could
reduce exposure to immune suppression, and add new therapeutic strategies that do not exist
at present.

Though diet has a significant impact on the composition of the microbiota no dietary
intervention to date has proven effective for induction of remission. The investigators
hypothesized that ulcerative colitis is caused by a series of events involving dysbiosis with
sulfate or sulfide reducing bacteria combined with defective production of short chain fatty
acids, coupled with a defective mucous layer.

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