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Decentralized Dietary UC Pilot Trial

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ClinicalTrials.gov Identifier: NCT02357537
Recruitment Status : Unknown
Verified November 2015 by Transparency Life Sciences.
Recruitment status was:  Recruiting
First Posted : February 6, 2015
Last Update Posted : November 6, 2015
Sponsor:
Information provided by (Responsible Party):
Transparency Life Sciences

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.

Condition or disease Intervention/treatment Phase
Colitis, Ulcerative Behavioral: Combined Anti-inflammatory Diet (CAID) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Health Services Research
Official Title: A Pilot Study Investigating a Decentralized Approach to Studying Dietary Intervention in Patients With Ulcerative Colitis
Study Start Date : January 2015
Estimated Primary Completion Date : December 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Traditional

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).

Behavioral: Combined Anti-inflammatory Diet (CAID)
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.

Active Comparator: Remote

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).

Behavioral: Combined Anti-inflammatory Diet (CAID)
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 Measures :
  1. Endoscopy Mayo Score Comparison (proportion of endoscopies to which an independent reader can successfully assign an endoscopic Mayo Clinic sub-score) [ Time Frame: Week 1 ]
    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.

  2. Compliance (proportion of missing or non-evaluable records per patient and the proportion of patients who did not complete the study) [ Time Frame: Week 7 ]
    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.

  3. Combined Anti-inflammatory Diet (Change from baseline in fecal calprotectin/microbiome levels) [ Time Frame: Weeks 0, 5 and 7 ]
    Change from baseline in fecal calprotectin/microbiome levels between Control (standard nutritional advice) and CAID (dietary intervention) arms.


Secondary Outcome Measures :
  1. Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index) [ Time Frame: Weeks 1 and 7 ]
    Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index between Control and CAID (dietary intervention).

  2. Adverse Events [ Time Frame: Weekly through week 11 ]
    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.

  3. Dietary Compliance Comparison [ Time Frame: Week 7 ]
    Comparison of patient non-compliance events with dietary regimen between arms 1 and 2.

  4. Participant Satisfaction Survey [ Time Frame: Week 7 ]
    Difference in reported patient satisfaction with trial participation between arms 1 and 2.

  5. Mayo Score Discrepancy Frequency [ Time Frame: Week 7 ]
    Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Endoscopy Sub-Scores for Arm 2 patients at baseline.

  6. Physician's Global Assessment Discrepancy Frequency [ Time Frame: Week 7 ]
    Frequency of discrepancy between Principal Investigator-assessed and gastroenterologist-assessed Mayo Clinic Physician's Global Assessment Sub-Score for Arm 2 patients at baseline.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02357537


Contacts
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Contact: Justine States (617) 732-9110 dietaryUCTrial@partners.org

Locations
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United States, Massachusetts
Crohn's and Colitis Center at Brigham and Women's Hospital Recruiting
Brookline, Massachusetts, United States, 02467
Contact: Justine States    617-732-9110    dietaryUCTrial@partners.org   
Principal Investigator: Joshua Korzenik, MD         
Sponsors and Collaborators
Transparency Life Sciences
Investigators
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Study Director: Tomasz Sablinski, MD, PhD Transparency Life Sciences
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Responsible Party: Transparency Life Sciences
ClinicalTrials.gov Identifier: NCT02357537    
Other Study ID Numbers: TLS-UC-003
First Posted: February 6, 2015    Key Record Dates
Last Update Posted: November 6, 2015
Last Verified: November 2015
Keywords provided by Transparency Life Sciences:
Telemedicine
Additional relevant MeSH terms:
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Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases
Anti-Inflammatory Agents