Decentralized Dietary UC Pilot Trial
Status unconfirmed · Not applicable
Conditions studied: Colitis, Ulcerative
In brief
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.
Key facts
- Study ID
- NCT02357537
- Run by
- Transparency Life Sciences
- People needed
- 51
- Starts
- 2015-01-01
- Last updated by the study team
- 2015-11-06
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Males and females between the ages of 18 and 80, inclusive, who reside in the state of Massachusetts.
- 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.
- Documented history of moderate to severe active UC
- Disease duration of ≥12 weeks at the time of screening (diagnosed according to American College of Gastroenterology practice guidelines)
- Screening fecal calprotectin>350 mg/g
- 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.
- Documented (via video or report) endoscopy performed within 2 years prior to randomization.
- Access to a computer or mobile device with internet connection and an active email address.
You may not qualify if…
- Prior extensive colonic resection, subtotal or total colectomy or planned surgery for UC
- Past or present ileostomy or colostomy
- Short bowel syndrome
- Diagnosis of indeterminate colitis, fulminant colitis, toxic megacolon
- Past or present fistula or abdominal abscess
- History or current evidence of colonic mucosal dysplasia
- Use of tube feeding, defined formula diets or parenteral alimentation/nutrition which has not been discontinued ≥3 weeks prior to study enrollment
- Use of anticoagulants, herbal supplements and omega-3/fish oil supplements during the study
- Crohn's Disease
- 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
- History of alcohol, drug or chemical abuse within 6 months prior to screening
- Pregnant females, those intending to become pregnant, and those who are lactating
- Current participation in any other clinical trial
Where it is running
- Crohn's and Colitis Center at Brigham and Women's Hospital — Brookline, Massachusetts, United States (enrolling)
Full record on ClinicalTrials.gov
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