Decentralized Dietary UC Pilot Trial

NCT02357537 | Unknown

• 1 other identifier: TLS-UC-003
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Colitis, Ulcerative

Keywords

Telemedicine

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (6)

• Mayo Score and Patient Simple Clinical Colitis Activity Index Difference (Difference in partial Mayo Clinic sub-Score and Patient Simple Clinical Colitis Activity Index)

  Weeks 1 and 7

• Adverse Events

  Weekly through week 11

• Dietary Compliance Comparison

  Week 7

• Participant Satisfaction Survey

  Week 7

• Mayo Score Discrepancy Frequency

  Week 7

Study Arms (2)

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).

Behavioral: Combined Anti-inflammatory Diet (CAID)

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).

Behavioral: Combined Anti-inflammatory Diet (CAID)

Interventions

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.

Remote; Traditional

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Transparency Life Sciences: lead

Study Sites (1)

Crohn's and Colitis Center at Brigham and Women's Hospital

Brookline, Massachusetts, 02467, United States

RECRUITING

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Tomasz Sablinski, MD, PhD

  Transparency Life Sciences

  STUDY DIRECTOR

Central Study Contacts

Justine States

CONTACT

(617) 732-9110; dietaryUCTrial@partners.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Last Updated: November 6, 2015

Record last verified: 2015-11

Locations

US (1)