Decentralized Dietary UC Pilot Trial



Status:Recruiting
Conditions:Colitis, Colitis, Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - 80
Updated:10/14/2017
Start Date:January 2015
Contact:Justine States
Email:dietaryUCTrial@partners.org
Phone:(617) 732-9110

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A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis

This study is designed to assess differences in remote and on-site patient study
participation in the State of Massachusetts, as well as the significance of dietary
interventions and their impact on UC. The study will activate one site with a Principal
Investigator who will utilize each subject's local care system (local Gastroenterologist) to
collect study data, along with telemonitoring and video visits, to make key study assessments
and decisions regarding subjects' progression in the study.


Inclusion Criteria:

1. Males and females between the ages of 18 and 80, inclusive, who reside in the state of
Massachusetts.

2. Ability and willingness to provide documented informed consent and to comply with the
study procedures, including in-person visits for Arm 1 and video visits for Arm 2.

3. Documented history of moderate to severe active UC

4. Disease duration of ≥12 weeks at the time of screening (diagnosed according to
American College of Gastroenterology practice guidelines)

5. Screening fecal calprotectin>350 mg/g

6. Diagnosis of moderately to severely active UC, including historical endoscopy sub
score ≥2; a rectal bleeding sub score ≥1 and disease activity a minimum of 25 cm from
the anal verge.

7. Documented (via video or report) endoscopy performed within 2 years prior to
randomization.

8. Access to a computer or mobile device with internet connection and an active email
address.

Exclusion Criteria:

1. Prior extensive colonic resection, subtotal or total colectomy or planned surgery for
UC

2. Past or present ileostomy or colostomy

3. Short bowel syndrome

4. Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon

5. Past or present fistula or abdominal abscess

6. History or current evidence of colonic mucosal dysplasia

7. Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which
has not been discontinued ≥3 weeks prior to study enrollment

8. Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the
study

9. Crohn's Disease

10. Significant uncontrolled co-morbidity, such as neurological, cardiac (e.g., moderate
to severe heart failure NYHA class III/IV), pulmonary, renal, hepatic, endocrine or
gastrointestinal disorders

11. History of alcohol, drug or chemical abuse within 6 months prior to screening

12. Pregnant females, those intending to become pregnant, and those who are lactating

13. Current participation in any other clinical trial
We found this trial at
1
site
Brookline, Massachusetts 02467
Principal Investigator: Joshua Korzenik, MD
Phone: 617-732-9110
?
mi
from
Brookline, MA
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