Microbiota-targeted Diet for Pediatric UC
| Status: | Recruiting |
|---|---|
| Conditions: | Colitis, Colitis, Gastrointestinal |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 8 - 19 |
| Updated: | 3/15/2019 |
| Start Date: | March 8, 2017 |
| End Date: | July 2019 |
| Contact: | Naomi Pressman |
| Email: | Pressmann@email.chop.edu |
| Phone: | 267-426-8413 |
Use of a Novel Diet (UC Diet) Targeting the Microbiota for Treatment of Mild to Moderate Active Pediatric Ulcerative Colitis: An Open Label Pilot Study
Ulcerative colitis is a chronic inflammatory disease primarily involving the colon and has
long been considered to be due to a dysregulated immune response targeting the colon, and
involves unknown environmental factors. Currently, no effective therapy targets the
microbiota or its interaction with the colonic epithelium. Diet has a significant impact on
the composition of the microbiota; however, no dietary intervention to date has proven
effective for induction of remission. The primary objective of this study is to determine
whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC
patients with active mild to moderate UC on a stable medication.
long been considered to be due to a dysregulated immune response targeting the colon, and
involves unknown environmental factors. Currently, no effective therapy targets the
microbiota or its interaction with the colonic epithelium. Diet has a significant impact on
the composition of the microbiota; however, no dietary intervention to date has proven
effective for induction of remission. The primary objective of this study is to determine
whether the Ulcerative Colitis Diet (UCD) can induce remission or response in pediatric UC
patients with active mild to moderate UC on a stable medication.
Inclusion Criteria:
- Informed consent
- Established diagnosis of UC
- Age: 8-19 (inclusive)
- Mild to moderate active disease, 10
- Stable medication (IMM/5ASA) use or no medication use for the past 6 weeks.
- Participant has agreed to follow the UCD for 12 weeks
Exclusion Criteria:
- Any proven current infection such as positive stool culture, parasite or C. difficile
within the past 4 weeks
- Antibiotic or corticosteroid use in the past 2 weeks
- Use of biologics in present or in the past
- PUCAI>45
- Acute severe UC in the previous 12 months
- Current extra intestinal manifestation of UC
- Primary Sclerosing Cholangitis (PSC) or liver disease
- Pregnancy
- Known food allergy to mandatory foods in the UCD
We found this trial at
1
site
South 34th Street
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
215-590-1000
Phone: 267-426-8414
Children's Hospital of Philadelphia Since its start in 1855 as the nation's first hospital devoted...
Click here to add this to my saved trials
