Back to resultsDecentralized Dietary UC Pilot Trial
Primary Purpose
Colitis, Ulcerative
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Combined Anti-inflammatory Diet (CAID)
Sponsored by
About this trial
This is an interventional health services research trial for Colitis, Ulcerative focused on measuring Telemedicine
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Crohn's and Colitis Center at Brigham and Women's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Traditional
Remote
Arm Description
Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits). Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).
Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4. Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).
Outcomes
Primary Outcome Measures
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
Secondary Outcome Measures
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
Adverse Events
Difference in incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) between Study Arms 1 and 2 and between Control and CAID (dietary intervention) arms.
Dietary Compliance Comparison
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
Participant Satisfaction Survey
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
Mayo Score Discrepancy Frequency
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
Physician's Global Assessment Discrepancy Frequency
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
Full Information
NCT ID
NCT02357537
First Posted
January 23, 2015
Last Updated
November 5, 2015
Sponsor
Transparency Life Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02357537
Brief Title
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
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Transparency Life Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colitis, Ulcerative
Keywords
Telemedicine
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
51 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Traditional
Arm Type
Active Comparator
Arm Description
Subjects in Study Arm 1 will undergo a screening process, and if randomized, will follow a traditional, site-based clinical trial model and undergo a baseline visit and 3 more in-person visits with the Principal Investigator (total of 4 visits).
Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).
Arm Title
Remote
Arm Type
Active Comparator
Arm Description
Subjects in Study Arm 2 will undergo a screening process, and if randomized, will undergo one Baseline visit at the local Gastroenterologist's office and 4 video visits with the Principal Investigator. A mobile nurse will visit subjects at a distant location (such as their home) to obtain blood samples at visits 1 and 4.
Subjects in each Study Arm will be randomized (2:1) to follow one of two dietary regimens during the study: the Combined Anti-Inflammatory Diet (CAID) or Control (standard nutritional advice).
Intervention Type
Behavioral
Intervention Name(s)
Combined Anti-inflammatory Diet (CAID)
Intervention Description
The CAID requires participants to modify their diet to include certain types of foods that may have anti-inflammatory properties. Participants on the CAID will be required to abstain from red meat and alcoholic beverages.
Primary Outcome Measure Information:
Title
Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score)
Description
Comparison of the proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score between Study Arms 1 and 2.
Time Frame
Week 1
Title
Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study)
Description
Comparison of the proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study between Study Arms 1 and 2.
Time Frame
Week 7
Title
Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels)
Description
Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.
Time Frame
Weeks 0, 5 and 7
Secondary Outcome Measure Information:
Title
Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)
Description
Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).
Time Frame
Weeks 1 and 7
Title
Adverse Events
Description
Difference in incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) between Study Arms 1 and 2 and between Control and CAID (dietary intervention) arms.
Time Frame
Weekly through week 11
Title
Dietary Compliance Comparison
Description
Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.
Time Frame
Week 7
Title
Participant Satisfaction Survey
Description
Difference in reported patient satisfaction with trial participation between arms 1 and 2.
Time Frame
Week 7
Title
Mayo Score Discrepancy Frequency
Description
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.
Time Frame
Week 7
Title
Physician's Global Assessment Discrepancy Frequency
Description
Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.
Time Frame
Week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Justine States
Phone
(617) 732-9110
Email
dietaryUCTrial@partners.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Sablinski, MD, PhD
Organizational Affiliation
Transparency Life Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Crohn's and Colitis Center at Brigham and Women's Hospital
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Justine States
Phone
617-732-9110
Email
dietaryUCTrial@partners.org
First Name & Middle Initial & Last Name & Degree
Joshua Korzenik, MD
12. IPD Sharing Statement
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Decentralized Dietary UC Pilot Trial
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