Clinical trial NCT02357537: Decentralized Dietary UC Pilot Trial
Official title: A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colitis, Ulcerative
Keywords: Telemedicine
Lead sponsor: Transparency Life Sciences
Sponsor class: INDUSTRY
First posted: 2015-02-06
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
timeFrame: Week 1
measure: Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
timeFrame: Week 7
measure: Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
timeFrame: Weeks 0, 5 and 7
Secondary outcomes:
measure: Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
timeFrame: Weeks 1 and 7
measure: Adverse Events
timeFrame: Weekly through week 11
measure: Dietary Compliance Comparison
timeFrame: Week 7
measure: Participant Satisfaction Survey
timeFrame: Week 7
measure: Mayo Score Discrepancy Frequency
timeFrame: Week 7
measure: Physician's Global Assessment Discrepancy Frequency
timeFrame: Week 7
Other outcomes:
Locations:
city: Brookline
country: United States
facility: Crohn's and Colitis Center at Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Transparency Life Sciences
name: Tomasz Sablinski, MD, PhD
role: STUDY_DIRECTOR
References: