Decentralized Dietary UC Pilot Trial

Transparency Life Sciences

Status: Unknown

Conditions: Colitis, Ulcerative

Treatments: Behavioral: Combined Anti-inflammatory Diet (CAID)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02357537

TLS-UC-003

Details and patient eligibility

About

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.

Enrollment: 51 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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51 participants in 2 patient groups

Traditional

Active Comparator group

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).

Treatment:

Behavioral: Combined Anti-inflammatory Diet (CAID)

Remote

Active Comparator group

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).

Treatment:

Behavioral: Combined Anti-inflammatory Diet (CAID)