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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traditional | Active Comparator | 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). |
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| Remote | Active Comparator | 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Combined Anti-inflammatory Diet (CAID) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 1 |
| 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. | Week 7 |
| 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. | Weeks 0, 5 and 7 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Weeks 1 and 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Justine States | Contact | (617) 732-9110 | dietaryUCTrial@partners.org |
| Name | Affiliation | Role |
|---|---|---|
| Tomasz Sablinski, MD, PhD | Transparency Life Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Crohn's and Colitis Center at Brigham and Women's Hospital | Recruiting | Brookline | Massachusetts | 02467 | United States |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 29, 2017 | |
| Reset | Jun 15, 2017 | |
| Release | Sep 19, 2017 | |
| Reset | Jul 12, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 29, 2017 | Jun 15, 2017 | |||
| Sep 19, 2017 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| 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. |
| Weekly through week 11 |
| Dietary Compliance Comparison | Comparison of patient non-compliance events with dietary regimen between arms 1 and 2. | Week 7 |
| Participant Satisfaction Survey | Difference in reported patient satisfaction with trial participation between arms 1 and 2. | Week 7 |
| 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. | Week 7 |
| 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. | Week 7 |
| Jul 12, 2018 |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |