Brookline, Massachusetts 02467


Purpose:

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.


Criteria:

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


NCT ID:

NCT02357537


Primary Contact:

Study Director
Tomasz Sablinski, MD, PhD
Transparency Life Sciences

Justine States
Phone: (617) 732-9110
Email: dietaryUCTrial@partners.org


Backup Contact:

N/A


Location Contact:

Brookline, Massachusetts 02467
United States

Justine States
Phone: 617-732-9110
Email: dietaryUCTrial@partners.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 18, 2017

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